In Vitro Maturation (IVM) as part of the treatment of infertility in women with polycystic ovaries (PCO). Is priming with hCG favourable? A prospective randomized study.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-000194-29-DK

Enrollment

200

Registered

2006-03-21

Start date

2006-04-11

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility in women with polycystic ovaries (PCO).

Interventions

Trade Name: Ovitrelle Product Name: Ovitrelle Product Code: hCG Pharmaceutical Form: Injection*

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Women referred to IVF/ICSI-treatment of infertility at the fertility clinic, Odense University Hospital, and with polycystic ovaries diagnosed by ultrasound imaging. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Normal morfology of the ovaries. Medical conditions requiring cronic medication, e.g. diabetes mellitus. Endocrine conditions, except PCOS, influencing on fertility, e.g. hyperprolactinamia, hyper-or hypothyroidism. Abuse of drugs or alcohole. More than two earlier IVF-treatments.

Design outcomes

Primary

Measure	Time frame
Main Objective: In a prospective randomized study to compare the effect of hCG priming versus no priming on the reproductive outcome of InVitroMaturation (IVM) in women with polycystic ovaries (PCO). Maturation rate= no. of mature eggs/ no. aspirated eggs in ICSI cycles Fertilization rate=no. of fertilized eggs / no. aspirated eggs in non-ICSI-cycles in the two groups.;Secondary Objective: No. of transferable embryons as a fraction of aspirated eggs, matured eggs and fertilized eggs in the two groups. Maturation rate in relation to follicle size. Maturation rate in relation to serum concentrations of estradiol, FSH, LH, AMH in cycle day 3,6, day of randomization and day of egg-aspiration.;Primary end point(s): Completed 9 weeks pregnancy, verified by ultrasound imaging.	—

Measure

Time frame

Main Objective: In a prospective randomized study to compare the effect of hCG priming versus no priming on the reproductive outcome of InVitroMaturation (IVM) in women with polycystic ovaries (PCO). Maturation rate= no. of mature eggs/ no. aspirated eggs in ICSI cycles Fertilization rate=no. of fertilized eggs / no. aspirated eggs in non-ICSI-cycles in the two groups.;Secondary Objective: No. of transferable embryons as a fraction of aspirated eggs, matured eggs and fertilized eggs in the two groups. Maturation rate in relation to follicle size. Maturation rate in relation to serum concentrations of estradiol, FSH, LH, AMH in cycle day 3,6, day of randomization and day of egg-aspiration.;Primary end point(s): Completed 9 weeks pregnancy, verified by ultrasound imaging.

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Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026