Trial Outcomes & Findings for Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05714 (Care Program)(P05715) (NCT NCT00702234)

Last Updated: 2024-09-05

Results Overview

The live birth rate was defined as the number of participants who had an ongoing pregnancy after a corifollitropin alfa COS cycle in base study P05714 (NCT00696878) and who had at least one live born infant during follow-up, divided by the number of participants treated in the base study. For this analysis, it was assumed that any participants with ongoing pregnancy after a COS cycle in base study who did not enroll in follow-up study P05715 had no live born infants.

Recruitment status

COMPLETED

Target enrollment

268 participants

Primary outcome timeframe

Up to approximately 32 months after first dose of corifollitropin alfa in base study P05714 (NCT00696878)

Results posted on

2024-09-05

Participant Flow

Of 272 participants with ongoing pregnancy at 10 weeks after fresh embryo transfer (ET) in base study P05714 (NCT00696878), 268 enrolled in this follow-up study P05715. A participant could enter follow-up study without meeting formal definition for "Completion" of base study.

To complete base study P05714 (NCT00696878), a participant must have embryo transfer in the 3rd Controlled Ovarian Stimulation (COS) cycle (Treatment Cycle 3). For this follow-up trial P05715, study completion for participant (expectant mother) or live born infant was defined as completion of infant follow-up visit at 4-12 weeks after delivery.

Participant milestones

Participant milestones
Measure	Women/Expectant Mothers - Corifollitropin Alfa 150 µg In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of Gonadotropin Releasing Hormone (GnRH) antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of recombinant Human Chorion Gonadotropin (\[rec\]hCG) (5,000-10,000 IU/250 µg). Daily dosing with Follicle Stimulating Hormone (FSH) (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.	Fetuses Present at 10 Weeks After Fresh ET in Base Study This group includes fetuses associated with expectant mothers who were administered corifollitropin alfa in base study P05714 (NCT00696878) who were enrolled in this follow-up study P05715. The fetuses were present at 10 weeks after fresh ET in base study P05714 and/or at enrollment of the expectant mother in this follow-up study P05715.
Base Study (NCT00696878) STARTED	682	0
Base Study (NCT00696878) COMPLETED	178	0
Base Study (NCT00696878) NOT COMPLETED	504	0
Follow-up Study: Expectant Mothers STARTED	268	0
Follow-up Study: Expectant Mothers COMPLETED	246	0
Follow-up Study: Expectant Mothers NOT COMPLETED	22	0
Follow-up Study: Fetuses/Infants STARTED	0	315
Follow-up Study: Fetuses/Infants Live Born Infants	0	304
Follow-up Study: Fetuses/Infants COMPLETED	0	288
Follow-up Study: Fetuses/Infants NOT COMPLETED	0	27

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05714 (Care Program)(P05715)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Expectant Mothers - Corifollitropin Alfa 150 µg n=268 Participants In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
Age, Continuous	32.8 years STANDARD_DEVIATION 3.3 • n=5 Participants
Sex: Female, Male Female	268 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 32 months after first dose of corifollitropin alfa in base study P05714 (NCT00696878)

Population: Participants administered corifollitropin alfa in base study P05714 (NCT00696878)

Outcome measures

Outcome measures
Measure	Women - Corifollitropin Alfa 150 µg n=682 Participants In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
Percentage of Women With Ongoing Pregnancy After a Corifollitropin Alfa COS Cycle in Base Study and ≥1 Live Born Infant During Follow-up (Live Birth Rate)	37.8 percentage of participants

PRIMARY outcome

Timeframe: From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months)

Population: Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in base study P05714 (NCT00696878) and who enrolled in the follow-up study.

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

Outcome measures
Measure	Women - Corifollitropin Alfa 150 µg n=268 Participants In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
Number of Expectant Mothers Experiencing Adverse Events (AEs)	203 participants

PRIMARY outcome

Timeframe: From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months)

Population: Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in base study P05714 (NCT00696878) and who enrolled in the follow-up study.

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

Outcome measures
Measure	Women - Corifollitropin Alfa 150 µg n=268 Participants In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
Number of Expectant Mothers Experiencing Serious AEs (SAEs)	145 participants

PRIMARY outcome

Timeframe: Up to 12 weeks after birth

Population: Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa in base study P05714 (NCT00696878) and who enrolled in the follow-up study.

Outcome measures

Outcome measures
Measure	Women - Corifollitropin Alfa 150 µg n=304 Participants In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
Number of Live Born Infants Experiencing AEs	99 participants

PRIMARY outcome

Timeframe: Up to 12 weeks after birth

Outcome measures

Outcome measures
Measure	Women - Corifollitropin Alfa 150 µg n=304 Participants In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
Number of Live Born Infants Experiencing SAEs	79 participants

Adverse Events

Expectant Mothers - Corifollitropin Alfa 150 µg

Serious events: 145 serious events

Other events: 0 other events

Deaths: 0 deaths

Fetuses Present at 10 Weeks After Fresh ET in Base Study

Serious events: 84 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

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 Publications must be based on data validated and released by the Sponsor. Any scientific paper, presentation, or other communication concerning the study must first be submitted to the Sponsor, at least 6 weeks prior to estimated publication or presentation, for written consent. Sponsor has the right to make its consent conditional upon proper representation of the interpretation of both the Sponsor and the Investigator in the discussion of the data in such communications.
Publication restrictions are in place

Restriction type: OTHER