hCG Priming in Women With Diminished Ovarian Reserve
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Infertility, Female, Ovarian Reserve, In Vitro Fertilization (IVF)
In brief
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.
Key facts
- Study ID
- NCT07108621
- Run by
- Kristine Loessl
- People needed
- 80
- Starts
- 2025-09-01
- Expected to finish
- 2031-03-31
- Last updated by the study team
- 2025-09-17
Who can join
Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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.
Where it is running
- Fertility Clinic, Department of Gynaecology, Fertility and Obstetrics, Copenhagen University Hosital Rigshospitalet — Copenhagen, Denmark (enrolling)
Full record on ClinicalTrials.gov
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