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New treatment option for Infertility, Female
Official title hCG Priming in Women With Diminished Ovarian Reserve
ClinicalTrials.gov ID: NCT07108621
What this study is testing
What is Choriongonadotropin alfa (hCG)?
Choriongonadotropin alfa (hCG) is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for infertility, female.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40, women only
You may be able to join 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 likely can't join if
- Uterine malformations or hydrosalpinx
- Submucosal uterine myomas
- Uterine polyps
- Allergy to standard IVF/ICSI medication
- Endometriosis stage III-IV
- Preimplantation genetic testing
See the full eligibility 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)
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.