Intrauterine Insemination and Luteal Fase Support

Infertility Clinical Trial

Official title:

Impact of Luteal Phase Support With Vaginal Progesterone on the Clinical Pregnancy Rate in Intrauterine Insemination Cycles Stimulated With Gonadotrophins: a Prospective Randomized Multicentre Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01826747
• Other study ID #: S52775
• Status: Completed
• Phase: Phase 4
• Start date: April 2011
• Est. completion date: June 2016

Study information

• Verified date: October 2018
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective is to test the hypothesis that luteal phase support with vaginal progesterone leads to a higher clinical pregnancy rate (primary outcome) and live birth rate (secondary outcome) when compared to no luteal phase support in a program of intrauterine insemination (IUI) after controlled ovarian stimulation with gonadotrophins. Additionally, the length of the luteal phase will be recorded (secondary outcome) in order to detect luteal phase defects/insufficiencies in the absence of luteal phase suppletion as well as luteal phase prolongation in case of luteal phase support which may be a burden for the patients waiting for the outcome of the treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 393
• Est. completion date: June 2016
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

Inclusion Criteria:

Patients with an indication for IUI:

• unexplained infertility

• mild male factor infertility

• minimal-mild endometriosis

Women:

• first IUI cycle ever

• normal ovulatory cycles (26-32d)

• age<43,BMI=30

• presence of at least one patent tube on hysterosalpingography and/or laparoscopy

• normal uterine cavity (ultrasound, hysterosalpingography, or laparoscopy)

Men: Total motile count = 5 Million/ml after capacitation

Exclusion Criteria:

• Patients with contra-indication for pregnancy , infertility or progesterone use.

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• crinone (progesterone 8%, vaginal application)

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical pregnancy rate per IUI cycle		by ultrasound at ± 5 to 6 weeks after IUI
Secondary	live birth rate per IUI cycle		40 weeks after IUI