Actively Recruiting
hCG Priming in Women With Diminished Ovarian Reserve
Led by Kristine Loessl · Updated on 2025-09-17
80
Participants Needed
1
Research Sites
291 weeks
Total Duration
On this page
Sponsors
K
Kristine Loessl
Lead Sponsor
C
Copenhagen University Hospital, Hvidovre
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
hCG Priming in Women With Diminished Ovarian Reserve
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-40 years inclusive
- Regular menstrual cycle of 23 to 35 days
- Between 1 and 5 IVF/ICSI cycles at inclusion
- Anti-Mullerian Hormone (AMH) level below 6.29 pmol/L measured by Elecsys4 AMH assay
You will not qualify if you...
- Uterine malformations or hydrosalpinx
- Submucosal uterine myomas
- Uterine polyps
- Allergy to standard IVF/ICSI medications
- Endometriosis stage III-IV
- Undergoing preimplantation genetic testing
- Use of testicular sperm aspiration or extraction
- Ovarian enlargement or cysts other than normal corpora lutea
- Unexplained gynecological bleeding
- Known severe medical conditions such as insulin-dependent or non-insulin-dependent diabetes mellitus, gastrointestinal, cardiovascular, thromboembolic disorders, pulmonary, liver or kidney diseases, HIV or Hepatitis B/C, thyroid disease, tumors of the hypothalamus or pituitary gland, or cancers of the ovary, uterus, or breast
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Trial Site Locations
Total: 1 location
1
Fertility Clinic, Department of Gynaecology, Fertility and Obstetrics, Copenhagen University Hosital Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
Research Team
K
Kristine Løssl, Associate Professor, PhD, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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