Phase 4
N=124
Progesterone Serum Levels in Subfertile Female Patients Undergoing in Vitro Fertilisation (IVF)
Infertility
Bottom Line
View on ClinicalTrials.gov: NCT01225835 ↗Enrolled (actual)
124
Serious AEs
1.6%
Results posted
Feb 2014
Primary outcome: Primary: Serum Progesterone (P4) Level in the Morning of the Day of Human Chorionic Gonadotrophin (hCG) Administration — 0.69; 0.72; 0.54; 0.89 ng/ml — p=0.003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Menotrophin (Drug); Follitrophin alpha (Drug); Cetrorelix (Drug); Choriongonadotropin (Drug); Progesterone (Drug)
- Age
- Adult · 34+ yrs
- Sex
- Female
- Sponsor
- Ferring Pharmaceuticals
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Progesterone (P4) Level in the Morning of the Day of Human Chorionic Gonadotrophin (hCG) Administration |
0.69; 0.72; 0.54; 0.89; 0.92; 0.80 | 0.003 sig |
| SECONDARY Receiver Operating Characteristic (ROC) Analysis of Progesterone as Predictor for Ongoing Pregnancy Rate at Day 7 and Day of hCG Administration |
0.5189; 0.4944 | — |
| SECONDARY Percentage of Participants With Ongoing Pregnancy |
29.2; 31.0 | 1.00 |
| SECONDARY Number of Follicles at hCG Administration |
8.7; 10.5 | 0.004 sig |
| SECONDARY Average Follicle Diameter at hCG Administration |
17.6; 18.1 | 0.121 |
| SECONDARY Number of Cumulus-oocyte Complexes Retrieved |
6.8; 10.0 | <0.001 sig |
| SECONDARY Number of Pronuclear Oocytes |
3.7; 5.9 | <0.001 sig |
| SECONDARY Number of Participants With Pronuclear Stage Oocytes at Each Quality Grade |
11; 17; 15; 23; 33; 40 | — |
| SECONDARY Number of Embryos Transferred |
2.0; 2.0 | 0.482 |
| SECONDARY Best Quality of an Embryo Transferred |
22; 26; 18; 22; 6; 6 | 0.871 |
| SECONDARY Number of Frozen Oocytes at Pronuclear Stage |
1.0; 2.7 | <0.001 sig |
| SECONDARY Endometrial Thickness on Day of hCG Administration |
10.8; 11.0 | 0.620 |
| SECONDARY Estradiol (E2) Levels on Day of hCG Administration |
1.81; 1.65 | 0.478 |
| SECONDARY Percentage of Participants With Successful Embryo Transfer |
4.2; 6.9; 95.8; 93.1 | 0.69 |
| SECONDARY Number of Days Stimulated With Gonadotrophins |
8.7; 9.1 | 0.295 |
| SECONDARY Number of Ampoules of Gonadotrophins Used |
20.8; 21.5 | 0.405 |
| SECONDARY Percentage of Participants With Clinical Pregnancy 6 Weeks After the First Positive Pregnancy Test |
29.2; 31.0 | 1.000 |
| SECONDARY Summary of Pregnancy Outcome |
13; 16; 1; 0; 0; 1 | — |
Summary
This study is aimed to demonstrate that highly purified Menotrophin produces significant lower progesterone serum levels during the follicular phase in comparison to Follitropin alpha in the treatment of subfertile females undergoing an in vitro fertilisation (IVF) and to investigate if the progesterone serum levels might be a useful predictor for the success rate of the ongoing pregnancy rates
Eligibility Criteria
Inclusion Criteria
- Signed informed consent
- Subfertile premenopausal female patients eligible for in vitro fertilisation (IVF) treatment
- Aged ≥34 and ≤42 years
- Body mass index of >18 and 3 months)
- A history of hypersensitivity to any of the constituents of the study medication or related compounds
- Diagnosed poor (<3 oocytes) responders to prior gonadotrophin stimulated ART-cycle
- History of severe ovarian hyperstimulation syndrome in former gonadotrophin stimulated assisted reproductive technology (ART)-cycle
Data sourced from ClinicalTrials.gov (NCT01225835). 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.