Trial Outcomes & Findings for Cumulative Pregnancy Rate With Lower and Higher Gonadotropin Dose During IVF Among Poor Responders (NCT NCT05103228)
NCT ID: NCT05103228
Last Updated: 2024-12-13
Results Overview
an ultrasound confirmation of an intrauterine gestational sac with an embryo with detectable heartbeat in it after the fresh + if available frozen embryo transfer treatments
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
190 participants
Primary outcome timeframe
18 months
Results posted on
2024-12-13
Participant Flow
Participant milestones
| Measure |
Lower Gonadotropin Dose Stimulation
Low-dose group:
* 150 IU follitropin alpha + 75 IU highly purified human menopausal gonadotropin (hpHMG)
* 10 mcg follitropin delta + 75 IU hpHMG
Follitropin Alfa: lower dose gonadotropin (follitropin alpha/ follitropin delta + hpHMG) vs. higher dose stimulation (Follitropin alpha/delta + hpHMG)
Follitropin delta: lower dose gonadotropin (follitropin alpha/ follitropin delta + hpHMG) vs. higher dose stimulation (Follitropin alpha/delta + hpHMG)
human menopausal gonadotropin: lower dose gonadotropin (follitropin alpha/ follitropin delta + hpHMG) vs. higher dose stimulation (Follitropin alpha/delta + hpHMG)
|
Higher Gonadotropin Dose Stimulation
High-dose group:
* 225 IU follitropin alpha + 150 IU highly purified human menopausal gonadotropin (hpHMG)
* 15 mcg follitropin delta + 150 IU hpHMG
Follitropin Alfa: lower dose gonadotropin (follitropin alpha/ follitropin delta + hpHMG) vs. higher dose stimulation (Follitropin alpha/delta + hpHMG)
Follitropin delta: lower dose gonadotropin (follitropin alpha/ follitropin delta + hpHMG) vs. higher dose stimulation (Follitropin alpha/delta + hpHMG)
human menopausal gonadotropin: lower dose gonadotropin (follitropin alpha/ follitropin delta + hpHMG) vs. higher dose stimulation (Follitropin alpha/delta + hpHMG)
|
|---|---|---|
|
Overall Study
STARTED
|
98
|
92
|
|
Overall Study
COMPLETED
|
94
|
91
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Lower Gonadotropin Dose Stimulation
n=94 Participants
Low-dose group:
* 150 IU follitropin alpha + 75 IU highly purified human menopausal gonadotropin (hpHMG)
* 10 mcg follitropin delta + 75 IU hpHMG
Follitropin Alfa: lower dose gonadotropin (follitropin alpha/ follitropin delta + hpHMG) vs. higher dose stimulation (Follitropin alpha/delta + hpHMG)
Follitropin delta: lower dose gonadotropin (follitropin alpha/ follitropin delta + hpHMG) vs. higher dose stimulation (Follitropin alpha/delta + hpHMG)
human menopausal gonadotropin: lower dose gonadotropin (follitropin alpha/ follitropin delta + hpHMG) vs. higher dose stimulation (Follitropin alpha/delta + hpHMG)
|
Higher Gonadotropin Dose Stimulation
n=91 Participants
High-dose group:
* 225 IU follitropin alpha + 150 IU highly purified human menopausal gonadotropin (hpHMG)
* 15 mcg follitropin delta + 150 IU hpHMG
Follitropin Alfa: lower dose gonadotropin (follitropin alpha/ follitropin delta + hpHMG) vs. higher dose stimulation (Follitropin alpha/delta + hpHMG)
Follitropin delta: lower dose gonadotropin (follitropin alpha/ follitropin delta + hpHMG) vs. higher dose stimulation (Follitropin alpha/delta + hpHMG)
human menopausal gonadotropin: lower dose gonadotropin (follitropin alpha/ follitropin delta + hpHMG) vs. higher dose stimulation (Follitropin alpha/delta + hpHMG)
|
Total
n=185 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.8 years
STANDARD_DEVIATION 3.3 • n=94 Participants
|
37.1 years
STANDARD_DEVIATION 3.6 • n=91 Participants
|
37.0 years
STANDARD_DEVIATION 3.4 • n=185 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=94 Participants
|
91 Participants
n=91 Participants
|
185 Participants
n=185 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=94 Participants
|
0 Participants
n=91 Participants
|
0 Participants
n=185 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Anti-Müllerian hormone
|
0.7 ng/ml
STANDARD_DEVIATION 0.3 • n=94 Participants
|
0.7 ng/ml
STANDARD_DEVIATION 0.2 • n=91 Participants
|
0.7 ng/ml
STANDARD_DEVIATION 0.2 • n=185 Participants
|
|
Antral follicle count
|
5.8 piece
STANDARD_DEVIATION 2.5 • n=94 Participants
|
6.0 piece
STANDARD_DEVIATION 2.5 • n=91 Participants
|
6.0 piece
STANDARD_DEVIATION 2.0 • n=185 Participants
|
|
Body mass index
|
23.8 kg/m^2
STANDARD_DEVIATION 4.4 • n=94 Participants
|
24.1 kg/m^2
STANDARD_DEVIATION 4.1 • n=91 Participants
|
23.8 kg/m^2
STANDARD_DEVIATION 4.6 • n=185 Participants
|
|
Cycle number
|
1.8 cycles
STANDARD_DEVIATION 1.1 • n=94 Participants
|
1.7 cycles
STANDARD_DEVIATION 1.0 • n=91 Participants
|
1.7 cycles
STANDARD_DEVIATION 1.0 • n=185 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: intention to treat
an ultrasound confirmation of an intrauterine gestational sac with an embryo with detectable heartbeat in it after the fresh + if available frozen embryo transfer treatments
Outcome measures
| Measure |
Lower Gonadotropin Dose Stimulation
n=94 Participants
Low-dose group:
* 150 IU follitropin alpha + 75 IU highly purified human menopausal gonadotropin (hpHMG)
* 10 mcg follitropin delta + 75 IU hpHMG
Follitropin Alfa: lower dose gonadotropin (follitropin alpha/ follitropin delta + hpHMG) vs. higher dose stimulation (Follitropin alpha/delta + hpHMG)
Follitropin delta: lower dose gonadotropin (follitropin alpha/ follitropin delta + hpHMG) vs. higher dose stimulation (Follitropin alpha/delta + hpHMG)
human menopausal gonadotropin: lower dose gonadotropin (follitropin alpha/ follitropin delta + hpHMG) vs. higher dose stimulation (Follitropin alpha/delta + hpHMG)
|
Higher Gonadotropin Dose Stimulation
n=91 Participants
High-dose group:
* 225 IU follitropin alpha + 150 IU highly purified human menopausal gonadotropin (hpHMG)
* 15 mcg follitropin delta + 150 IU hpHMG
Follitropin Alfa: lower dose gonadotropin (follitropin alpha/ follitropin delta + hpHMG) vs. higher dose stimulation (Follitropin alpha/delta + hpHMG)
Follitropin delta: lower dose gonadotropin (follitropin alpha/ follitropin delta + hpHMG) vs. higher dose stimulation (Follitropin alpha/delta + hpHMG)
human menopausal gonadotropin: lower dose gonadotropin (follitropin alpha/ follitropin delta + hpHMG) vs. higher dose stimulation (Follitropin alpha/delta + hpHMG)
|
|---|---|---|
|
Cumulative Clinical Pregnancy Rate
|
27 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intentition to treat population
delivery of a viable newborn after 24 weeks gestation
Outcome measures
| Measure |
Lower Gonadotropin Dose Stimulation
n=94 Participants
Low-dose group:
* 150 IU follitropin alpha + 75 IU highly purified human menopausal gonadotropin (hpHMG)
* 10 mcg follitropin delta + 75 IU hpHMG
Follitropin Alfa: lower dose gonadotropin (follitropin alpha/ follitropin delta + hpHMG) vs. higher dose stimulation (Follitropin alpha/delta + hpHMG)
Follitropin delta: lower dose gonadotropin (follitropin alpha/ follitropin delta + hpHMG) vs. higher dose stimulation (Follitropin alpha/delta + hpHMG)
human menopausal gonadotropin: lower dose gonadotropin (follitropin alpha/ follitropin delta + hpHMG) vs. higher dose stimulation (Follitropin alpha/delta + hpHMG)
|
Higher Gonadotropin Dose Stimulation
n=91 Participants
High-dose group:
* 225 IU follitropin alpha + 150 IU highly purified human menopausal gonadotropin (hpHMG)
* 15 mcg follitropin delta + 150 IU hpHMG
Follitropin Alfa: lower dose gonadotropin (follitropin alpha/ follitropin delta + hpHMG) vs. higher dose stimulation (Follitropin alpha/delta + hpHMG)
Follitropin delta: lower dose gonadotropin (follitropin alpha/ follitropin delta + hpHMG) vs. higher dose stimulation (Follitropin alpha/delta + hpHMG)
human menopausal gonadotropin: lower dose gonadotropin (follitropin alpha/ follitropin delta + hpHMG) vs. higher dose stimulation (Follitropin alpha/delta + hpHMG)
|
|---|---|---|
|
Live Birth Rate
|
15 live births
|
10 live births
|
SECONDARY outcome
Timeframe: 12 monthsCumulative live birth: delivery of a viable newborn after 24 weeks gestation after the fresh embryo transfer or if it is unsuccessful but surplus embryos were frozen then after any of the subsequent frozen embryo transfer cycles. All these transfers (fresh and frozen) are the result of a single stimulation. If a live birth is reached during the fresh or any of the subsequent frozen transfers from the same stimulation then it is considered a positive outcome; if the fresh transfer or any of the subsequent frozen transfers from the same stimulation do not result in a live birth it is considered a negative result.
Outcome measures
| Measure |
Lower Gonadotropin Dose Stimulation
n=94 Participants
Low-dose group:
* 150 IU follitropin alpha + 75 IU highly purified human menopausal gonadotropin (hpHMG)
* 10 mcg follitropin delta + 75 IU hpHMG
Follitropin Alfa: lower dose gonadotropin (follitropin alpha/ follitropin delta + hpHMG) vs. higher dose stimulation (Follitropin alpha/delta + hpHMG)
Follitropin delta: lower dose gonadotropin (follitropin alpha/ follitropin delta + hpHMG) vs. higher dose stimulation (Follitropin alpha/delta + hpHMG)
human menopausal gonadotropin: lower dose gonadotropin (follitropin alpha/ follitropin delta + hpHMG) vs. higher dose stimulation (Follitropin alpha/delta + hpHMG)
|
Higher Gonadotropin Dose Stimulation
n=91 Participants
High-dose group:
* 225 IU follitropin alpha + 150 IU highly purified human menopausal gonadotropin (hpHMG)
* 15 mcg follitropin delta + 150 IU hpHMG
Follitropin Alfa: lower dose gonadotropin (follitropin alpha/ follitropin delta + hpHMG) vs. higher dose stimulation (Follitropin alpha/delta + hpHMG)
Follitropin delta: lower dose gonadotropin (follitropin alpha/ follitropin delta + hpHMG) vs. higher dose stimulation (Follitropin alpha/delta + hpHMG)
human menopausal gonadotropin: lower dose gonadotropin (follitropin alpha/ follitropin delta + hpHMG) vs. higher dose stimulation (Follitropin alpha/delta + hpHMG)
|
|---|---|---|
|
Cumulative Live Birth Rate
|
17 live births
|
13 live births
|
Adverse Events
Lower Gonadotropin Dose Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Higher Gonadotropin Dose Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Peter Kovacs
Dunamenti REK IVF Center (former Kaali Institute)
Phone: +3612022802
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place