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

Wael Elbanna Clinic

Status: Completed

Conditions: Female Infertility

Treatments: Drug: HCG is introduced at day of trigger intra-uterine; Device: endometrial injury by pipelle

Study type: Observational

Funder types: Other

Identifiers

NCT05050747

Elbanna_002

Details and patient eligibility

About

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.

Full 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

Enrollment: 402 patients

Sex: Female

Ages: 25 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

402 participants in 3 patient groups

Arm 1

Description:

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

Treatment:

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

Arm 2

Description:

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

Treatment:

Device: endometrial injury by pipelle

Arm 3

Description:

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