The effect of progesterone supplementation on pregnancy rates in controlled ovarian stimulation and intrauterine insemination cycles: a randomized prospective trial

Phase 2

• Conditions: Condition 1: Female infertility, unspecified. Condition 2: Male infertility.; inability to achieve a pregnancy; Azoospermia NOS

• Registration Number: IRCT201104266292N1
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

All women included in the study were between the age 18 and 35 years and BMI of 18-28 kg/m2, regular mense, and no PCOD (according to Rotterdam criteria), basal FSH<10 IU/L and normal serum prolactin level and normal thyroid function. All couples had been trying unsuccessfully to conceive for at least one year before being enrolled in the trial. All women had bilateral tubal patency and normal uterine cavity, confirmed by hysterosalpinography (HSG), performed a maximum of 6 months before the start the stimulation. Men had at least two semen analyses before any treatment. Normal semen analysis were defined by the threshold values of the World Health Organization criteria, =4% sperm had normal morphology according to the criteria of Kruger et al, or total motile sperm count = 1 million following semen preparation
Exclusion criteria: abnormal prolactin serum level and abnormal thyroid function test, polycystic ovary syndrome according to Rotterdam criteria, diminished ovarian reserve (basal FSH level >10 IU/mL, presence of resistant ovarian cyst (>20mm for > 1 months), hypogonadotrophic hypogonadism or any contraindications for progesterone therapy

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate. Timepoint: 4 weeks after insemination. Method of measurement: Transvaginal sonography.

Secondary Outcome Measures

Name	Time	Method
Ovulation rate. Timepoint: The days 12, 14 cycles. Method of measurement: Transvaginal sonography.