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

An Open-label Prospective Controlled Study to Assess the Effect of Intrauterine Adminstration of HCG Versus Endometrial Injury by Pipelle on the Ongoing Pregnancy Rate in Patients With Unexplained Infertility Undergoing Ovulation Induction

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.

Study Overview

• Status: Recruiting
• Conditions: Female Infertility
• Intervention / Treatment: Drug: hCG

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 Type: Observational
• Enrollment (Anticipated): 402

Contacts and Locations

• Study Contact: Name: Manal El-Hinnawi El-Hinnawi, M.Sc.; Phone Number: 01007970546; Email: manalelhinnawi@hotmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Wael Elbanna Clinic
    • Contact: manal elhinnawi; Phone Number: 01007970546; Email: manalelhinnawi@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 33 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Arm 1; Women with unexplained infertility undergoing ovulation induction following intrauterine adminstration of HCG on the day of trigger	Drug: hCG; endometrial injury by pipelle on day 8-9 of the same cycle of ovulation induction; Other Names: pipelle
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
occurance of abortion or ectopic or multiple pregnancy	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	Till the end of the 1st trimester
Recording the baseline characteristics of the study participants	age , height , weight , body mass index	Before study intervention

Collaborators and Investigators

• Sponsor: Wael Elbanna Clinic
• Collaborators: National Research Centre, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2021
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: August 13, 2021
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (Actual): September 21, 2021

Study Record Updates

• Last Update Posted (Actual): December 10, 2021
• Last Update Submitted That Met QC Criteria: November 27, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Female
• Other Study ID Numbers: Elbanna_002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No