Eight Weeks of Low Dose hCG Priming in Women With Diminished Ovarian Reserve Undergoing IVF/ICSI - a Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:
• Age 18-40 (both inclusive)
• Regular menstrual cycle (23-35 days)
• 1.-5. IVF/ICSI cycle at inclusion
• AMH \< 6.29 pmol/L (Elecsys® AMH assay)
Locations
Other Locations
Denmark
Fertility Clinic, Department of Gynaecology, Fertility and Obstetrics, Copenhagen University Hosital Rigshospitalet
RECRUITING
Copenhagen
Contact Information
Primary
Kristine Løssl, Associate Professor, PhD, MD
kristine.loessl@regionh.dk
+4535451077
Time Frame
Start Date:2025-09
Estimated Completion Date:2031-03-31
Participants
Target number of participants:80
Treatments
Experimental: hCG Priming
Women in the experimental group will undergo the following treatment in order:~A standard IVF/ICSI cycle (ICSI I): A standard IVF/ICSI cycle in the fixed GnRH-antagonist protocol using a daily dose of 300 IU rFSH initiated from cd 2-3 and a GnRH antagonist (Ganirelix 0.25 mg) from stimulation day 5-6 followed by blastocyst culture and a freeze-all strategy.~Priming period: hCG priming 260 IU once daily for two menstrual cycles (approximately 8 weeks).~A standard IVF/ICSI cycle (ICSI I): A standard IVF/ICSI cycle in the fixed GnRH-antagonist protocol using a daily dose of 300 IU rFSH initiated from cd 2-3 and a GnRH antagonist (Ganirelix 0.25 mg) from stimulation day 5-6 followed by blastocyst culture and a single blastocyst transfer at day 5.
Placebo_comparator: Placebo
Women in the placebo group will undergo the following treatment in order:~A standard IVF/ICSI cycle (ICSI I): A standard IVF/ICSI cycle in the fixed GnRH-antagonist protocol using a daily dose of 300 IU rFSH initiated from cd 2-3 and a GnRH antagonist (Ganirelix 0.25 mg) from stimulation day 5-6 followed by blastocyst culture and a freeze-all strategy.~Priming period: Placebo (isotone NaCl) injections once daily for two menstrual cycles (approximately 8 weeks).~A standard IVF/ICSI cycle (ICSI I): A standard IVF/ICSI cycle in the fixed GnRH-antagonist protocol using a daily dose of 300 IU rFSH initiated from cd 2-3 and a GnRH antagonist (Ganirelix 0.25 mg) from stimulation day 5-6 followed by blastocyst culture and a single blastocyst transfer at day 5.