The effect of growth hormone on increasing pregnancy success rate in women with unexplained recurrent implantation failure: A multicenter clinical randomized study.

Phase 3

Recruiting

• Conditions: Condition 1: Patients with recurrent implantation failure. Condition 2: Patients with recurrent implantation failure.; Complications of attempted introduction of fertilized ovum following in vitro fertilization; Female infertility of uterine origin; N98.2; N97.2

• Registration Number: IRCT20201003048912N1
• Lead Sponsor: Avicenna Reseacrh Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 356

Inclusion Criteria

have a history of more than two previous unexplained IVF failures (3=)(despite transfer of minimum one good grade A blastocyst embryo) , no previous hormone growth cycle, no other interventions in this cycle(hystroscopy and Imunomodolator drugs ), no donation cycle, no hormone contraindications, not having hydrosalpinx, , having at least one good grade A blastocyst freezed embryo for transfer , FSH=10, AMH=1.8

Exclusion Criteria

Age= 40 years, BMI=30, endometriosis, severe oligospermia, (Sperm count <5 ×106 /mL ,Normal morphology <2% in the sperm analysis test ) DFI =30% , patients with hydrosalpinx, kidney and liver diseases, diabetes,hypertention and thyroid( anti-Tpo>500) and autoimmune diseases and local allergic reactions and benign increase in intracranial pressure, submucosal myoma, metabolic syndrome, sex selection , karyotype disorder, uterian anomalis, Synechsia, Hx of thin enodmetrium(endometrial line<7mm) , no patient consent

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pregnancy rate. Timepoint: 5-6 weeks after taking the drug. Method of measurement: The number of patients with positive gestational sac divided by the number of patients who had embryo transfer.

Secondary Outcome Measures

Name	Time	Method
Endometrial receptivity. Timepoint: 2 weeks after taking the drug. Method of measurement: measurement of sub endometrial flow by power Doppler sono and endometrial volume and thickness by 3D and 2D ultrasonograghy.;Chemical pregnancy rate : the rate of positive pregnancy test 2 weeks after embryo transfer. Timepoint: 2 weeks after embryo transfer. Method of measurement: evaluation of positive pregnancy test after transfer of blastocyst (s) embryo(s).;Implantation rate. Timepoint: measurement of number gestational sac divided by number of blastocyst embryo transfer. Method of measurement: evaluation of positive and number of intrauterine gestational sac after transfer of blastocyst (s) embryo(s) by ultrasonograghy.;Live birth rate : number of delivery of viable fetuses(more than 28 weeks) divided by number of embryo transferred. Timepoint: Gestational age more than 28 weeks of pregnancy. Method of measurement: Delivery of viable fetuses after 28 after pregnancy.