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

Completed

• Conditions: Female Infertility
• Interventions: Drug: HCG is introduced at day of trigger intra-uterine; Device: endometrial injury by pipelle

• Registration Number: NCT05050747
• Lead Sponsor: Wael Elbanna Clinic

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.

Detailed Description

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:

Arm 1: Women with unexplained infertility undergoing ovulation induction following intrauterine adminstration of HCG on the day of trigger 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 Arm 3: Women with unexplained infertility undergoing ovulation induction following intrauterine adminstration of placebo on the day of trigger

Primary and secondary key measurements will be used in the study.

The primary measures will include:

* 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

The secondary key measures will include:

* Occurance of abortion in the 1st trimester

* Appearance of ectopic pregnancy diagnosis by:

Ultrasound Serum β-HCG level Symptoms of pain and bleeding

* Signs of multiple pregnancy Number of intrauterine gestational sacs Number of fetal poles Number of fetal heart pulsations

* Recording the the baseline characteristics of the study participants

Study Timeline

• Study First Submitted: 2021-08-13
• Status Verified: 2021-09
• Study First Submitted QC: 2021-09-09
• Study First Posted: 2021-09-21
• Study Start: 2021-09-27
• Primary Completion: 2024-08-25
• Study Completion: 2024-11-12
• Last Update Submitted: 2025-02-16
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 402

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm 1	HCG is introduced at day of trigger intra-uterine	Women with unexplained infertility undergoing ovulation induction following intrauterine adminstration of HCG on the day of trigger
Arm 2	endometrial injury by pipelle	Women with unexplained infertility undergoing ovulation induction following endometrial injury by pipelle on day 8-9 of the same cycle of ovulation induction

Primary Outcome Measures

Name	Time	Method
Signs of ongoing pregnancy	Till the end of the 1st trimester	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

Secondary Outcome Measures

Name	Time	Method
occurance of abortion or ectopic or multiple pregnancy	Till the end of the 1st trimester	Recording the following for the three arms of the study: * Occurance of abortion in the 1st trimester; * Appearance of ectopic pregnancy diagnosis by: Ultrasound Serum β-HCG level Symptoms of pain and bleeding; - Signs of multiple pregnancy Number of intrauterine gestational sacs Number of fetal poles Number of fetal heart pulsations
Recording the baseline characteristics of the study participants	Before study intervention	age , height , weight , body mass index

Trial Locations

Locations (1)

Wael Elbanna Clinic; 🇪🇬 Cairo, Egypt