Study to Assess the Effect of Intrauterine Adminstration of HCG Versus Endometrial Injury by Pipelle

NCT05050747 | Completed

• 1 other identifier: Elbanna_002
• Study Type: observational
• Target: 402
• Locations: 1 country
• Sites: 1

Brief Summary

Our study aims to describe the effect of the intrauterine adminstration of HCG versus the endometrial injury by pipelle on the ongoing pregnancy rate and the biochemical pregnancy rate in women with unexplained infertility undergoing ovulation induction. Also to describe the effect on the first trimester miscarriage rate, ectopic pregnancy rate, and multiple pregnancy.This study is an open-label, prospective, controlled study, multi-center study. The study participants' relevant medical records will be collected and reviewed after obtaining informed consent for the participants. The study materials that will be used will include blood tests, and ultrasound. The study will involve three study arms.

Conditions

Female Infertility

Outcome Measures

Primary Outcomes (1)

• Signs of ongoing pregnancy

  Recording the following for the three arms of the study: * Signs of ongoing pregnancy Presence of intrauterine gestational sac at 12 weeks Presence of fetal heart pulsation at 12 weeks * Two serum β-HCG levels in 48hrs interval to emphasis biochemical pregnancy

  Till the end of the 1st trimester

Secondary Outcomes (2)

• occurance of abortion or ectopic or multiple pregnancy

  Till the end of the 1st trimester

• Recording the baseline characteristics of the study participants

  Before study intervention

Study Arms (3)

Arm 1

Women with unexplained infertility undergoing ovulation induction following intrauterine adminstration of HCG on the day of trigger

Drug: HCG is introduced at day of trigger intra-uterine

Arm 2

Women with unexplained infertility undergoing ovulation induction following endometrial injury by pipelle on day 8-9 of the same cycle of ovulation induction

Device: endometrial injury by pipelle

Arm 3

Women with unexplained infertility undergoing ovulation induction following intrauterine adminstration of placebo on the day of trigger

Interventions

HCG is introduced at day of trigger intra-uterine DRUG

hcg is introduced

Arm 1

endometrial injury by pipelle DEVICE

endometrial injury using pipelle on day 8-9 on the same cycle of ovulation

Arm 2

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include women with unexplained infertility undergoing ovulation induction following either: 1. Intrauterine adminstration of HCG 2. Endometrial injury by pipelle 3. Intrauterine adminstration of placebo

You may qualify if:

• Women with primary or secondary infertility due to unexplained infertility
• The age group of these women was 25-35 years
• BMI 18.5-29.9 kg/m2
• Normal hormone profile (FSH \<10 mIU/ml on day 2-3 and AMH more than 1)
• Euthyroid state or controlled thyroid state
• Bilateral free spill on HSG

You may not qualify if:

• Patients with severe male factor infertility; serum analysis count \< 10 million sperms /mL - sperm motility\<15% - 96%\<abnormal morphology)
• Stage III or IV endometriosis
• Bilateral tubal factor infertility
• Premature ovarian failure
• Polycystic ovary syndrome
• Uterine cavity abnormality
• Recurrent spontaneous abortion

Sponsors & Collaborators

• Wael Elbanna Clinic: lead
• National Research Centre, Egypt: collaborator

Study Sites (1)

Wael Elbanna Clinic

Cairo, Egypt

Location

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Managing director for Wael Elbanna Clinic

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: September 21, 2021
• Study Start: September 27, 2021
• Primary Completion: August 25, 2024
• Study Completion: November 12, 2024
• Last Updated: February 19, 2025

Record last verified: 2021-09

Locations

EG (1)