Intrauterine Insemination and Luteal Fase Support

Universitaire Ziekenhuizen KU Leuven393 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

393

Conditions

Infertility

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 43 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

clinical pregnancy rate per IUI cycle

Time frame: by ultrasound at ± 5 to 6 weeks after IUI

Secondary Outcomes

live birth rate per IUI cycle

Time frame: 40 weeks after IUI