Phase 4 N=48 Randomized Double-blind Treatment

Double Pick up in Poor Prognosis Women

Fertility Disorders

Bottom Line

View on ClinicalTrials.gov: NCT03846544 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2024

Primary outcome: Primary: Number of MII Oocytes Retrieved Between the Two Arms — 4.1; 3.0 number of oocytes

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Corifollitoropin alfa (CFA)-double pick up (Drug)
Age: Adult · 25+ yrs
Sex: Female
Sponsor: CRG UZ Brussel
Primary completion: Sep 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of MII Oocytes Retrieved Between the Two Arms	4.1; 3.0	—
SECONDARY Number of Preovulatory Follicles	5.4; 5.0	—
SECONDARY Number of Cumulus Oocyte Complexes (COCs) Retrieved	5.3; 3.3	—
SECONDARY Number of Oocytes Fertilized	3.7; 2.3	—
SECONDARY Total Number of Available Embryos	1.5; 1.4	—
SECONDARY Duration of Ovarian Stimulation	9.9; 9.9	—
SECONDARY Clinical Pregnancy Rates	7; 13	—
SECONDARY Live Birth Rates	6; 8	—
SECONDARY Cumulative Live Birth Rates	—	—

Summary

The purpose of this randomized pilot study is to compare the efficacy of double oocyte retrieval vs. conventional antagonist ovarian stimulation protocol in poor prognosis patients undergoing in vitro fertilization (IVF) or intra-cytoplasmic sperm injection (ICSI).

Eligibility Criteria

Inclusion Criteria

Age 25-40 years
Body mass index (BMI) ≤ 35 and ≥ 19
Antimüllerian hormone (AMH) level of ≤1.5 ng/mL or antral follicular count (AFC) of ≤6 follicles or ≤5 oocytes retrieved in a previous cycle following standard conventional ovarian stimulation.

Exclusion Criteria

Testicular sperm extraction
History of > 3 three consecutive previous unsuccessful IVF cycles
BMI >35 or <19
Use of oral contraceptives <3 months before start of the treatment
polycystic ovary syndrome (PCOS) according to the Rotterdam criteria
Ovarian stimulation for pre-implantation genetic testing (PGT-A/M)
Medical/social freezing
In vitro maturation (IVM)
History of untreated autoimmune, endocrine or metabolic disorders,
Ovarian cystectomy or oophorectomy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03846544). 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.