hCG Priming in Women With Diminished Ovarian Reserve
Eight Weeks of Low Dose hCG Priming in Women With Diminished Ovarian Reserve Undergoing IVF/ICSI - a Randomized Controlled Trial
Kristine Loessl
80 participants
Sep 1, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- Age 18-40 (both inclusive)
- Regular menstrual cycle (23-35 days)
- IVF/ICSI cycle at inclusion
- AMH \< 6.29 pmol/L (Elecsys® AMH assay)
Exclusion Criteria11
- Uterine malformations or hydrosalpinx
- Submucosal uterine myomas
- Uterine polyps
- Allergy to standard IVF/ICSI medication
- Endometriosis stage III-IV
- Preimplantation genetic testing
- Testicular sperm aspiration/extraction
- Ovarian enlargement or cysts (other than normally occurring corpora luteae)
- Gynaecological haemorrhages of unknown aetiology
- Known severe comorbidity\*
- i.e., Insulin dependent diabetes mellitus, non-insulin dependent diabetes mellitus, gastrointestinal, cardiovascular, thromboembolic (including active thromboembolic disorders), pulmonary, liver or kidney diseases, HIV or Hepatitis B/C, dysregulated thyroid disease, tumors of the hypothalamus or pituitary gland or ovarian, uterine, or mammary carcinoma.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
hCG 260 IU once daily for two menstrual cycles (aproximately 8 weeks) prior til standard IVF/ICSI.
Placebo priming (isotone NaCl) once daily for two menstrual cycles (approximately 8 weeks) prior to standard IVF/ICSI.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07108621