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RECRUITING
NCT07108621
PHASE3

hCG Priming in Women With Diminished Ovarian Reserve

Sponsor: Kristine Loessl

View on ClinicalTrials.gov

Summary

The aim of this randomized controlled trial is to further examine the possible effects of low dose human chorionic gonadotropin (hCG) priming for eight weeks in women with diminished ovarian reserve (DOR) undergoing in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI). The investigators want to retest the findings of our first study in an identical paired design (NCT04643925), as an increase of 1.5 in mean number of oocytes retrieved is clinically relevant. To incorporate the strengths of a randomized controlled trial design, women will be randomized after their first ICSI treatment to receive either hCG or placebo in a double-blinded design during an eight-week priming period preceding their second ICSI treatment. The primary outcome is the number of oocytes retrieved in the second ICSI treatment.

Official title: Eight Weeks of Low Dose hCG Priming in Women With Diminished Ovarian Reserve Undergoing IVF/ICSI - a Randomized Controlled Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2025-09

Completion Date

2031-03-31

Last Updated

2025-09-17

Healthy Volunteers

No

Interventions

DRUG

Choriongonadotropin alfa (hCG)

hCG 260 IU once daily for two menstrual cycles (aproximately 8 weeks) prior til standard IVF/ICSI.

DRUG

Isotonic NaCl (Placebo)

Placebo priming (isotone NaCl) once daily for two menstrual cycles (approximately 8 weeks) prior to standard IVF/ICSI.

Locations (1)

Fertility Clinic, Department of Gynaecology, Fertility and Obstetrics, Copenhagen University Hosital Rigshospitalet

Copenhagen, Denmark