Intrauterine Insemination and Luteal Fase Support

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

393 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2016-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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experimental

Luteal Phase support

Group Type EXPERIMENTAL

crinone (progesterone 8%, vaginal application)

Intervention Type DRUG

control

No luteal Phase support

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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crinone (progesterone 8%, vaginal application)

Intervention Type DRUG

Eligibility Criteria

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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