Phase 4
N=137
The Evaluation of Recombinant LH Supplementation in Patients With Suboptimal Response to Recombinant FSH Undergoing ICSI
Infertility
Bottom Line
View on ClinicalTrials.gov: NCT02108223 ↗Enrolled (actual)
137
Serious AEs
—
Results posted
Aug 2014
Primary outcome: Primary: Pregnancy Rate — 64.7; 57.8; 32.4 percentage of pregnant participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- fix dose r-FSH (Gonal-f) (Drug); r-LH supplementation (Drug); r-FSH (Gonal-f) (Drug)
- Age
- Adult · 23+ yrs
- Sex
- Female
- Sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pregnancy Rate |
64.7; 57.8; 32.4 | — |
| SECONDARY the Number of Oocytes Retrieved |
10.8; 6.6; 6.4 | — |
| SECONDARY Number of Mature Oocyte |
8.9; 5.5; 5.5 | — |
| SECONDARY Fertilization Rate |
73.1; 74.9; 74.7 | — |
| SECONDARY Implantation Rates |
34.8; 36.1; 15 | — |
Summary
The investigators aimed to evaluate patients who had In-vitro fertilization treatment and who had COH (controlled ovarian hyperstimulation) cycles applying long protocol with GnRH (gonadotropin-releasing hormone) analogue with suboptimal response to the rFSH. The investigators evaluated and compared the addition of rLH, increasing the dose of rFSH and the control groups regarding the results of IVF in these patients.
Eligibility Criteria
Inclusion Criteria
- Patients aged 23-39
- Body mass index between 18 and 30 kg/m2
- Baseline FSH ≤12 IU/l, E2 ≤ 80 pg/ml
- The presence of both ovaries and uterine cavity capable of sustaining a pregnancy
- Who had regular menstrual cycles (21-35 days) Confirmed absence of pregnancy and sufficient number of antral follicles on the transvaginal US examination on the 3rd day of menstruation
- Who were having their first or second IVF trial.
Exclusion Criteria
- Grade III-IV endometriosis
- Clinically significant condition preventing them from undergoing gonadotrophin treatment
- More than two previous assisted cycles
- Who had a single ovary
- Unexplained gynaecological bleeding
- Polycystic ovary or an ovarian cyst of unknown aetiology
- Previously diagnosed with a space occupying lesion like submucous myoma , polyps, septum, synechia in the uterine cavity
- Have a chromosomal anomaly.
Data sourced from ClinicalTrials.gov (NCT02108223). 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.