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| Name | Class |
|---|---|
| National Research Centre, Egypt | OTHER |
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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.
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:
The secondary key measures will include:
Ultrasound Serum β-HCG level Symptoms of pain and bleeding
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HCG is introduced at day of trigger intra-uterine | Drug | hcg is introduced |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Signs of ongoing pregnancy | Recording the following for the three arms of the study:
| Till the end of the 1st trimester |
| Measure | Description | Time Frame |
|---|---|---|
| occurance of abortion or ectopic or multiple pregnancy | Recording the following for the three arms of the study:
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 |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include women with unexplained infertility undergoing ovulation induction following either:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wael Elbanna Clinic | Cairo | Egypt |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| endometrial injury by pipelle |
| Device |
endometrial injury using pipelle on day 8-9 on the same cycle of ovulation |
|
| Recording the baseline characteristics of the study participants | age , height , weight , body mass index | Before study intervention |
| D000091662 | Genital Diseases |
| D007246 | Infertility |