Intrauterine Insemination and Luteal Fase Support

Universitaire Ziekenhuizen KU Leuven

Status and phase: Completed; Phase 4

Conditions: Infertility

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01826747

S52775

Details and patient eligibility

About

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.

Enrollment: 393 patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

393 participants in 2 patient groups

experimental

Experimental group

Description:

Luteal Phase support

Treatment:

Drug: crinone (progesterone 8%, vaginal application)

control

No Intervention group

Description:

No luteal Phase support