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

Female Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05050747
• Other study ID #: Elbanna_002
• Status: Recruiting
• Start date: November 27, 2021
• Est. completion date: August 2023

Study information

• Verified date: August 2021
• Source: Wael Elbanna Clinic
• Contact: Wael Saad Saad El Banna El Banna, MD
• Phone: +2 01227760402
• Email: dr.wael.ss.elbanna[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 402
• Est. completion date: August 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Female Infertility
• Infertility
• Infertility, Female

Intervention

Drug:
• hCG
endometrial injury by pipelle on day 8-9 of the same cycle of ovulation induction

Locations

Country	Name	City	State
Egypt	Wael Elbanna Clinic	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Wael Elbanna Clinic	National research centre

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ß-HCG levels in 48hrs interval to emphasis biochemical pregnancy	Till the end of the 1st trimester
Secondary	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 ß-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
Secondary	Recording the baseline characteristics of the study participants	age , height , weight , body mass index	Before study intervention