hCG Priming in Women With Diminished Ovarian Reserve

What Was Tested

This registered phase 3 trial tested hCG (human chorionic gonadotropin) for female fertility.

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.

It had two arms (groups): hCG Priming (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Eligible women with DOR fulfilling the inclusion criteria and none of the exclusion criteria and with an indication for IVF/ICSI are enrolled.

Women can participate only once.

Eight weeks of hCG/placebo priming corresponds to two natural menstrual cycles.

A freeze-all strategy is applied in the first ICSI treatment.

Who Took Part

80 planned participants were the target.

It was open to women only aged from 18 years up to 40 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 18-40 (both inclusive). Regular menstrual cycle (23-35 days). 1.-5. IVF/ICSI cycle at inclusion.

The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: uterine malformations or hydrosalpinx; submucosal uterine myomas; uterine polyps.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got hCG (human chorionic gonadotropin) and who got the comparison, which limits bias.

The hCG (human chorionic gonadotropin) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the female fertility participants and researchers unaware of who received hCG (human chorionic gonadotropin).

Those kept unaware of assignments: participant and investigator.

It started in 2026-01-25 with completion listed for 2028-03-31.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of oocytes retrieved (time frame: Through study completion, an average of 4 months).

It also tracked 1 secondary outcome, for example Number of mature oocytes.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of hCG (human chorionic gonadotropin) in 80 people with female fertility.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the hCG (human chorionic gonadotropin) compound page, Female fertility research.