Trial Outcomes & Findings for Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05693 (P05713) (NCT NCT00702338)
NCT ID: NCT00702338
Last Updated: 2024-09-05
Results Overview
The Take-Home Baby Rate was defined as the number of participants with an ongoing pregnancy in base study P05693 (NCT00697255) with at least one live born infant in the current follow-up study divided by the total number of participants treated in base study P05693.
Recruitment status
COMPLETED
Target enrollment
1 participants
Primary outcome timeframe
From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to time of birth on current follow-up study (up to 1 year)
Results posted on
2024-09-05
Participant Flow
Participants treated with either corifollitropin alfa + recombinant Follicular Stimulating Hormone (recFSH) or corifollitropin alfa + Human Chorion Gonadotropin (hCG) in P05693 (NCT00697255) and with an ongoing pregnancy were to be recruited for the following study.
Of 8 participants treated with corifollitropin alfa + recFSH (5) or hCG (3) in base study P05693 (NCT00697255), one participant from the corifollitropin alfa + hCG group was enrolled in the current follow-up study with an ongoing multiple pregnancy. No participants from the corifollitropin alfa + recFSH group enrolled in the current follow-up study
Participant milestones
| Measure |
Corifollitropin Alfa + recFSH Mothers
Eligible participants in Stage 1a of base study P05693 (NCT00697255) were administered injection(s) with subcutaneous (SC) corifollitropin alfa (15mcg) and daily SC injections with recFSH (50 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then to be followed for safety and efficacy on the current follow-up (FU) study (P05713) according to standard practice (no treatment administered).
|
Corifollitropin Alfa + hCG Mothers
Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
|
Corifollitropin Alfa + hCG FU-Infants
Infants that were born to eligible mothers who received SC corifollitropin alfa plus SC hCG on base study P05693 (NCT00697255) were followed for safety and efficacy on the current follow-up study (P05713) according to standard practice.
|
|---|---|---|---|
|
Base Study (NCT00697255)
STARTED
|
5
|
3
|
0
|
|
Base Study (NCT00697255)
COMPLETED
|
2
|
1
|
0
|
|
Base Study (NCT00697255)
NOT COMPLETED
|
3
|
2
|
0
|
|
Follow-up Study: Expectant Mothers FU
STARTED
|
0
|
1
|
0
|
|
Follow-up Study: Expectant Mothers FU
COMPLETED
|
0
|
0
|
0
|
|
Follow-up Study: Expectant Mothers FU
NOT COMPLETED
|
0
|
1
|
0
|
|
Follow-up Study: Infant FU
STARTED
|
0
|
0
|
2
|
|
Follow-up Study: Infant FU
COMPLETED
|
0
|
0
|
0
|
|
Follow-up Study: Infant FU
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05693 (P05713)
Baseline characteristics by cohort
| Measure |
Corifollitropin Alfa + hCG Mothers
n=1 Participants
Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
|
|---|---|
|
Age, Continuous
|
31 years
STANDARD_DEVIATION 0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to time of birth on current follow-up study (up to 1 year)Population: Intent-to-Treat group (ITT) consisted of all treated participants in base study P05693 (NCT00697255): 5 participants in Stage Ia and 3 participants in Stage Ib.
The Take-Home Baby Rate was defined as the number of participants with an ongoing pregnancy in base study P05693 (NCT00697255) with at least one live born infant in the current follow-up study divided by the total number of participants treated in base study P05693.
Outcome measures
| Measure |
Corifollitropin Alfa + recFSH Mothers
n=5 Participants
Eligible participants in Stage 1a of base study P05693 (NCT00697255) were administered injection(s) with subcutaneous (SC) corifollitropin alfa (15mcg) and daily SC injections with recFSH (50 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then to be followed for safety and efficacy on the current follow-up (FU) study (P05713) according to standard practice (no treatment administered).
|
Corifollitropin Alfa + hCG Mothers
n=3 Participants
Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
|
|---|---|---|
|
Percentage of Mothers With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate): Protocol Defined
|
0.0 percentage of participants
|
33.3 percentage of participants
|
PRIMARY outcome
Timeframe: From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to time of birth on current follow-up study (up to 1 year)Population: Participants in the Intent-to-Treat group (ITT) in base study P05693 (NCT00697255) that received bolus injection of hCG.
Take-Home Baby Rate was alternately defined ad hoc as the number of participants with an ongoing pregnancy in base study P05693 (NCT00697255) with at least one live born infant in the current follow-up study divided by the total number of participants who received bolus injection of hCG in the base study.
Outcome measures
| Measure |
Corifollitropin Alfa + recFSH Mothers
n=2 Participants
Eligible participants in Stage 1a of base study P05693 (NCT00697255) were administered injection(s) with subcutaneous (SC) corifollitropin alfa (15mcg) and daily SC injections with recFSH (50 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then to be followed for safety and efficacy on the current follow-up (FU) study (P05713) according to standard practice (no treatment administered).
|
Corifollitropin Alfa + hCG Mothers
n=1 Participants
Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
|
|---|---|---|
|
Percentage of Mothers With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate): Alternate Analysis
|
0.0 percentage of participants
|
100.0 percentage of participants
|
PRIMARY outcome
Timeframe: From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 1 day after birth on current follow-up study (up to 1 year)Population: Follow-up safety analysis was performed on the one expectant mother who received corifollitropin alfa + hCG on the base study P05693 (NCT00697255) and who enrolled on the follow-up study. No mothers receiving corifollitropin alfa + recFSH in the base study were enrolled in this follow-up study or included in safety analyses.
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Outcome measures
| Measure |
Corifollitropin Alfa + recFSH Mothers
Eligible participants in Stage 1a of base study P05693 (NCT00697255) were administered injection(s) with subcutaneous (SC) corifollitropin alfa (15mcg) and daily SC injections with recFSH (50 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then to be followed for safety and efficacy on the current follow-up (FU) study (P05713) according to standard practice (no treatment administered).
|
Corifollitropin Alfa + hCG Mothers
n=1 Participants
Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
|
|---|---|---|
|
Number of Mothers With Adverse Events (AEs) During Follow-up
|
—
|
1 participants
|
PRIMARY outcome
Timeframe: From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 1 day after birth on current follow-up study (up to 1 year)Population: Follow-up safety analysis was performed on the one expectant mother who received corifollitropin alfa + hCG on the base study P05693 (NCT00697255) and who enrolled on the follow-up study. No mothers receiving corifollitropin alfa + recFSH in the base study were enrolled in this follow-up study or included in safety analyses.
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.
Outcome measures
| Measure |
Corifollitropin Alfa + recFSH Mothers
Eligible participants in Stage 1a of base study P05693 (NCT00697255) were administered injection(s) with subcutaneous (SC) corifollitropin alfa (15mcg) and daily SC injections with recFSH (50 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then to be followed for safety and efficacy on the current follow-up (FU) study (P05713) according to standard practice (no treatment administered).
|
Corifollitropin Alfa + hCG Mothers
n=1 Participants
Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
|
|---|---|---|
|
Number of Mothers With Serious AEs (SAEs) During Follow-up
|
—
|
1 participants
|
PRIMARY outcome
Timeframe: From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 12 weeks after birth on current follow-up studyPopulation: Follow-up safety analysis was performed on the fetuses/infants delivered by the one expectant mother who received corifollitropin alfa + hCG on the base study P05693 (NCT00697255) and who enrolled on the follow-up study. There were no other eligible infants to be evaluated for safety.
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Outcome measures
| Measure |
Corifollitropin Alfa + recFSH Mothers
n=2 Participants
Eligible participants in Stage 1a of base study P05693 (NCT00697255) were administered injection(s) with subcutaneous (SC) corifollitropin alfa (15mcg) and daily SC injections with recFSH (50 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then to be followed for safety and efficacy on the current follow-up (FU) study (P05713) according to standard practice (no treatment administered).
|
Corifollitropin Alfa + hCG Mothers
Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
|
|---|---|---|
|
Number of Infants With AEs During Follow-up
|
2 participant
|
—
|
PRIMARY outcome
Timeframe: From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 12 weeks after birth on current follow-up studyPopulation: Follow-up safety analysis was performed on the fetuses/infants delivered by the one expectant mother who received corifollitropin alfa + hCG on the base study P05693 (NCT00697255) and who enrolled on the follow-up study. There were no other eligible infants to be evaluated for safety.
An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Outcome measures
| Measure |
Corifollitropin Alfa + recFSH Mothers
n=2 Participants
Eligible participants in Stage 1a of base study P05693 (NCT00697255) were administered injection(s) with subcutaneous (SC) corifollitropin alfa (15mcg) and daily SC injections with recFSH (50 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then to be followed for safety and efficacy on the current follow-up (FU) study (P05713) according to standard practice (no treatment administered).
|
Corifollitropin Alfa + hCG Mothers
Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
|
|---|---|---|
|
Number of Infants With SAEs During Follow-up
|
2 participants
|
—
|
Adverse Events
Corifollitropin Alfa + hCG Mothers
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Corifollitropin Alfa + hCG FU-Infants
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Corifollitropin Alfa + hCG Mothers
n=1 participants at risk
Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
|
Corifollitropin Alfa + hCG FU-Infants
n=2 participants at risk
Infants that were born to eligible mothers who received SC corifollitropin alfa plus SC hCG on base study P05693 (NCT00697255) were followed for safety and efficacy on the current follow-up study (P05713) according to standard practice.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Premature labour
|
100.0%
1/1 • Number of events 1 • From ≥10 weeks after bolus injection of hCG on base study P05693 (NCT00697255) up to 1 day after birth on current follow-up study (up to 1 year) for mother, planned up to 12 weeks after birth on current follow-up study for infants.
Adverse events were reported for the one expectant mother who enrolled in this follow-up study and her 2 infants that were delivered on this study. No mothers receiving corifollitropin alfa + recFSH in the base study were enrolled in this follow-up study or included in safety analyses.
|
0.00%
0/2 • From ≥10 weeks after bolus injection of hCG on base study P05693 (NCT00697255) up to 1 day after birth on current follow-up study (up to 1 year) for mother, planned up to 12 weeks after birth on current follow-up study for infants.
Adverse events were reported for the one expectant mother who enrolled in this follow-up study and her 2 infants that were delivered on this study. No mothers receiving corifollitropin alfa + recFSH in the base study were enrolled in this follow-up study or included in safety analyses.
|
|
Pregnancy, puerperium and perinatal conditions
Premature baby
|
0.00%
0/1 • From ≥10 weeks after bolus injection of hCG on base study P05693 (NCT00697255) up to 1 day after birth on current follow-up study (up to 1 year) for mother, planned up to 12 weeks after birth on current follow-up study for infants.
Adverse events were reported for the one expectant mother who enrolled in this follow-up study and her 2 infants that were delivered on this study. No mothers receiving corifollitropin alfa + recFSH in the base study were enrolled in this follow-up study or included in safety analyses.
|
100.0%
2/2 • Number of events 2 • From ≥10 weeks after bolus injection of hCG on base study P05693 (NCT00697255) up to 1 day after birth on current follow-up study (up to 1 year) for mother, planned up to 12 weeks after birth on current follow-up study for infants.
Adverse events were reported for the one expectant mother who enrolled in this follow-up study and her 2 infants that were delivered on this study. No mothers receiving corifollitropin alfa + recFSH in the base study were enrolled in this follow-up study or included in safety analyses.
|
Other adverse events
| Measure |
Corifollitropin Alfa + hCG Mothers
n=1 participants at risk
Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
|
Corifollitropin Alfa + hCG FU-Infants
n=2 participants at risk
Infants that were born to eligible mothers who received SC corifollitropin alfa plus SC hCG on base study P05693 (NCT00697255) were followed for safety and efficacy on the current follow-up study (P05713) according to standard practice.
|
|---|---|---|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
100.0%
1/1 • Number of events 1 • From ≥10 weeks after bolus injection of hCG on base study P05693 (NCT00697255) up to 1 day after birth on current follow-up study (up to 1 year) for mother, planned up to 12 weeks after birth on current follow-up study for infants.
Adverse events were reported for the one expectant mother who enrolled in this follow-up study and her 2 infants that were delivered on this study. No mothers receiving corifollitropin alfa + recFSH in the base study were enrolled in this follow-up study or included in safety analyses.
|
0.00%
0/2 • From ≥10 weeks after bolus injection of hCG on base study P05693 (NCT00697255) up to 1 day after birth on current follow-up study (up to 1 year) for mother, planned up to 12 weeks after birth on current follow-up study for infants.
Adverse events were reported for the one expectant mother who enrolled in this follow-up study and her 2 infants that were delivered on this study. No mothers receiving corifollitropin alfa + recFSH in the base study were enrolled in this follow-up study or included in safety analyses.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee All publications must be based on data validated and released by the Sponsor. Any such scientific paper, presentation, or other communication concerning the clinical trial described in the protocol will first be submitted to the Sponsor, at least 6 weeks ahead of estimated publication or presentation, for written consent, which shall not be withheld unreasonably.
- Publication restrictions are in place
Restriction type: OTHER