Low-dose hCG priming before IVF for women with diminished ovarian reserve
Official title: Eight Weeks of Low Dose hCG Priming in Women With Diminished Ovarian Reserve Undergoing IVF/ICSI - a Randomized Controlled Trial
Run by Copenhagen University Hospital, Rigshospitalet · NCT07108621 · Data updated 2026-11-12
This trial will test whether daily low-dose hCG injections for eight weeks before a second IVF/ICSI cycle help women with diminished ovarian reserve produce more eggs.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 40 Years |
| Sex | Women only |
| Enrollment | 80 (estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet Academic / other |
| Locations | 1 site (Copenhagen) |
| Status | Recruiting |
| Started | January 25, 2026 |
| Main results expected | March 31, 2028 |
| Study ends | March 31, 2031 |
| Registry record updated | September 21, 2026 |
| Trial ID | NCT07108621 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–40 with regular menstrual cycles, AMH below 6.29 pmol/L, an indication for IVF/ICSI, and between one and five prior IVF/ICSI cycles are the intended participants.
✕Probably not a fit
Women with uterine malformations, hydrosalpinx, large fibroids/polyps, stage III–IV endometriosis, need for preimplantation genetic testing or surgically retrieved sperm, active severe comorbidity, or who fall outside the age/AMH criteria are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, double-blinded, placebo-controlled trial enrolling women with diminished ovarian reserve who undergo two identical ICSI cycles separated by an eight-week priming period. After the first ICSI (freeze-all), participants are randomized to daily low-dose hCG (260 IU) or placebo injections for eight weeks (two natural cycles) before a second ICSI cycle. Both cycles follow a fixed GnRH-antagonist protocol with 300 IU rFSH and routine monitoring, and the primary outcome is the number of oocytes retrieved in the second ICSI treatment. The multicenter study is conducted at four public fertility clinics in Denmark.
Why it matters
Potential benefit: If successful, this approach could help women with diminished ovarian reserve yield more eggs from IVF and potentially improve their chances of pregnancy.
How similar studies have gone: A prior paired study by the same investigators suggested an average increase of about 1.5 oocytes with hCG/androgen priming, and this randomized double-blind trial is designed to confirm that finding.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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's running
-
Fertility Clinic, Department of Gynaecology, Fertility and Obstetrics, Copenhagen University Hosital Rigshospitalet
Copenhagen, Denmark Recruiting
Study contacts
- Study coordinator: Kristine Løssl, Associate Professor, PhD, MD
- Email: kristine.loessl@regionh.dk
- Phone: +4535451077
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.