Phase 3
N=105
Administration of Follicle-stimulating Hormone (FSH) and Low Dose Human Chorionic Gonadotropin (hCG) for Oocyte Maturity While Decreasing hCG Exposure in In Vitro Fertilization (IVF) Cycles
Infertility
Bottom Line
View on ClinicalTrials.gov: NCT02310919 ↗Enrolled (actual)
105
Serious AEs
1.0%
Results posted
Apr 2022
Primary outcome: Primary: Total Fertilization Proportion (i.e. Total Competent Proportion) — 0.59; 0.65 ratio
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Low dose hCG plus FSH co-trigger (Drug); Standard dose of hCG (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of California, San Francisco
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Fertilization Proportion (i.e. Total Competent Proportion) |
0.59; 0.65 | — |
| SECONDARY Number of Oocytes Retrieved |
13.6; 16.1 | 0.06 |
| SECONDARY Number of MII Oocytes |
10.8; 12.5 | 0.13 |
| SECONDARY Total Oocyte Maturity Rate |
0.75; 0.77 | 0.47 |
| SECONDARY Mature Oocyte Recovery Proportion |
0.81; 0.92 | 0.01 sig |
| SECONDARY ICSI Fertilization Rate |
0.80; 0.80 | 0.95 |
| SECONDARY High Quality Cleavage-stage Embryos |
0.59; 0.62 | 0.52 |
| SECONDARY High Quality Blastocyst Embryos |
0.67; 0.68 | 0.87 |
| SECONDARY Livebirth Rate From All Fresh Transfers |
15; 13 | 1.0 |
| SECONDARY Bloating Score |
2.0; 2.0 | 0.98 |
| SECONDARY Abdominal Circumference |
0.38; 1.00 | 0.39 |
| SECONDARY Body Weight |
0.10; 0.05 | 0.41 |
| SECONDARY Serum hCG T+1 |
56.1; 267.4 | <0.001 sig |
| SECONDARY Serum FSH T+1 |
29.6; 19.0 | <0.001 sig |
| SECONDARY Serum P4 on T+1 |
6.1; 7.0 | 0.08 |
| SECONDARY Serum E2 on T+1 |
4010; 2763 | <0.001 sig |
| SECONDARY Serum LH on T+1 |
1.75; 1.70 | 0.67 |
| SECONDARY Serum hCG on T+2 |
52.6; 271.3 | <0.001 sig |
| SECONDARY Serum FSH on T+2 |
20.5; 12.0 | <0.001 sig |
| SECONDARY Serum P4 on T+2 |
10.7; 10.0 | 0.49 |
| SECONDARY Serum E2 on T+2 |
1773; 955 | <0.001 sig |
| SECONDARY Serum HCG on T+5 |
9.5; 52.1 | <0.001 sig |
| SECONDARY Serum FSH on T+5 |
5.1; 3.2 | <0.001 sig |
| SECONDARY Serum LH on T+5 |
0.65; 0.61 | 0.16 |
| SECONDARY Follicular hCG |
11.6; 135.3 | <0.001 sig |
| SECONDARY Follicular FSH |
13.1; 9.2 | <0.001 sig |
| SECONDARY Follicular P4 |
26095; 28758 | 0.95 |
| SECONDARY Follicular E2 |
842.2; 672.7 | 0.07 |
| SECONDARY Follicular VEGF |
3436; 3470 | 0.66 |
Summary
This is a randomized, double-blind, single center clinical trial study to compare oocyte competence and risk of ovarian hyperstimulation syndrome (OHSS) after receiving the standard dose of human chorionic gonadotropin (hCG) ovulation trigger or a lower dose of hCG plus concomitant follicle stimulating hormone (FSH) co-trigger in women undergoing in vitro fertilization (IVF).
Eligibility Criteria
Inclusion Criteria: The target population includes couples undergoing IVF. All eligible couples will be asked to join the study. Study participants will be recruited from the Reproductive Endocrinology Clinic at University of California at San Francisco Center for Reproductive Health. Patients receiving any type of stimulation protocol for IVF will be offered participation in the study.
Exclusion Criteria
- Age >41 years old
- Antral Follicle Count (AFC; 2-10 mm) 30 kg/m2
- History of ≥ 2 prior canceled IVF cycles secondary to poor response
- Diagnosis of cancer
- Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow-up, or interpretation of study results
- Undergoing embryo co-culture
- Use of any of the following medications: Growth Hormone, Sildenafil, or Aspirin (except if being used for hypercoagulable state)
- Severe male factor infertility diagnosis. Male factor infertility diagnosis should be cleared for eligibility by the PI based on previous patient history of fertilization outcomes and/or expected fertilization outcomes of the cause of male factor infertility based on known scientific data.
- Ovulation trigger less than or greater than 36 hours to oocyte retrieval
- Serum estradiol level >5, 000 pg/ml on the day of expected trigger due to high risk of OHSS
Data sourced from ClinicalTrials.gov (NCT02310919). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.