Endometrial Injury Versus Luteal Phase Support in Intrauterine Insemination Cycles

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Status: Terminated

Conditions: Pregnancy

Treatments: Drug: progesterone (Crinone® %8 vaginal progesterone gel); Other: Endometrial Injury

Study type: Interventional

Funder types: Other

Identifiers

NCT02492451

zeynepkamil

Details and patient eligibility

About

The investigators will try to assess the effect of endometrial injury preceding the intrauterine insemination cycle on the pregnancy rates compared to cycles with luteal phase support and the control group.

Full description

Group 1: Endometrial biopsy is performed on days 21-24 of the spontaneous menstrual cycle proceeding the intrauterine insemination (IUI) treatment cycle. Two small biopsies are obtained from anterior and posterior walls of the uterus.

Group 2: Vaginal progesterone gel is administered for luteal phase support from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.

Goup 3: Patients are undergone intrauterine insemination (IUI) cycles stimulated with gonadotropin without any intervention.

The effect of endometrial injury and luteal phase progesterone support on the pregnancy rate in patients intrauterine insemination (IUI) cycles stimulated with gonadotropin will be compared in terms of biochemical pregnancy rate, clinical pregnancy rate and ongoing pregnancy rate.

Enrollment: 118 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients are undergone intrauterine insemination with gonadotropin stimulation
• Bilateral patent fallopian tubes revealed by hysterosalpingography or laparoscopy
• After semen preparation for intrauterine insemination, total progressive sperm count > 5 million

Exclusion criteria

• endocrin or metabolic disorders,
• uterine factor,
• pelvic inflammatory disease,
• women with basal follicle-stimulating hormone (FSH) level >15 IU/mL,
• body mass index (BMI) ≥ 35 kg/m2,
• age ≥ 40 and < 18 years,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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118 participants in 3 patient groups

Endometrial Injury

Active Comparator group

Description:

Endometrial injury in luteal phase of preceding IUI cycle

Treatment:

Other: Endometrial Injury

Luteal Phase Support

Active Comparator group

Description:

Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.

Treatment:

Drug: progesterone (Crinone® %8 vaginal progesterone gel)

Control group

No Intervention group

Description:

Only IUI