NCT07108621 hCG Priming in Women With Diminished Ovarian Reserve
| NCT ID | NCT07108621 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Kristine Loessl |
| Condition | Infertility, Female |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-09 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 80 participants in total. It began in 2025-09 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07108621 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Infertility, Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07108621 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 80 participants.
Is NCT07108621 currently recruiting?
Yes, NCT07108621 is actively recruiting participants. Contact the research team at kristine.loessl@regionh.dk for enrollment information.
Where is the NCT07108621 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT07108621 clinical trial?
NCT07108621 is sponsored by Kristine Loessl. The trial plans to enroll 80 participants.