A prospective randomized multicentre study to compare Crinone 8% once daily versus other vaginal progesterone.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001248-22-DK

Enrollment

2686

Registered

2005-09-23

Start date

2006-02-21

Completion date

Unknown

Last updated

2021-04-19

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

Conditions

Luteal support in connnection with IVF treatment.

Interventions

Product Name: Crinone 8% Product Code: Not applicable Pharmaceutical Form: Vaginal gel INN or Proposed INN: Crinone CAS Number: Progesteron Concentration unit: % percent Product Name: Progesteron "DA

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Women =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Women who are not willing to sign Informed Consent form.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to show equivalence in ongoing pregnancy per embryo transfer (ET) between the two groups;Secondary Objective: To show that Crinone 8% is superior to other vaginal progesterone in terms of convenience. Other secondary objectives are to compare positive hCG, implantation rate, bleeding pattern before pregnancy test, live birth rate and multiple live birth rate.;Primary end point(s): On-going pregancy per ET minimum 5 weeks after ET	—

Measure

Time frame

Main Objective: The primary objective is to show equivalence in ongoing pregnancy per embryo transfer (ET) between the two groups;Secondary Objective: To show that Crinone 8% is superior to other vaginal progesterone in terms of convenience. Other secondary objectives are to compare positive hCG, implantation rate, bleeding pattern before pregnancy test, live birth rate and multiple live birth rate.;Primary end point(s): On-going pregancy per ET minimum 5 weeks after ET

—

Countries

Denmark, Sweden

Outcome results

None listed

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