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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05050747
Other study ID # Elbanna_002
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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