The Value of Addition of Human Menopausal Gonadotropin Drug Following Oocytes Retrieval in IVF Cycles
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ClinicalTrials.gov Identifier: NCT03209687 |
Recruitment Status :
Recruiting
First Posted : July 6, 2017
Last Update Posted : January 27, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Infertility | Drug: human menopausal gonadotropin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 600 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Human Menopausal Gonadotropin as a Novel Addition to Luteal Phase Support in Down-regulated ICSI Cycles (RCT) |
Actual Study Start Date : | July 6, 2017 |
Estimated Primary Completion Date : | July 15, 2022 |
Estimated Study Completion Date : | August 15, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Human menopausal gonadotropin (HMG)
This group will take daily subcutaneous 75 IU (international unit) of human menopausal gonadotropin (HMG) in addition to the usual luteal phase support from the day of ovum pickup and will be continued for 2 weeks
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Drug: human menopausal gonadotropin
Merional injections will be given to participants after ovum pickup in in-vitro fertilization cycles
Other Name: Merional |
No Intervention: Routine care
This group will receive the routine care for luteal phase support
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- Live birth rate [ Time Frame: This outcome will be calculated 2 years after enrollment of the first patient in the study ]The live birth rate will be calculated by a statistician for each group
- Clinical pregnancy rate [ Time Frame: This outcome will be calculated 2 years after enrollment of the first patient in the study ]The clinical pregnancy rate will be calculated by a statistician for each group
- Implantation rate [ Time Frame: This outcome will be calculated 2 years after enrollment of the first patient in the study ]The implantation rate will be calculated by a statistician for each group
- Miscarriage rate [ Time Frame: This outcome will be calculated 2 years after enrollment of the first patient in the study ]The miscarriage rate will be calculated by a statistician for each group

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Ages Eligible for Study: | 20 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Females undergoing Intra-Cytoplasmic Sperm Injection (ICSI) cycles
- Age between 20 and 40 years
Exclusion Criteria:
- Females who have high response (estradiol at time of ovulation trigger is > 5000 pg/ml or more than 15 oocytes are retrieved)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209687
Contact: Eman Omran, M.D. | 00223682030 | eman.omran@kasralaini.edu.eg | |
Contact: Doaa Belal, M.D. | 00223682030 | doaash@live.com |
Egypt | |
Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital | Recruiting |
Cairo, Greater Cairo, Egypt, 11956 | |
Contact: Eman Omran, M.D. +20223682030 eman.omran@kasralainy.edu.eg | |
Contact: Doaa Belal, M.D. +20223682030 doaash@live.com | |
Principal Investigator: Abdelmaguid Ramzy, M.D. | |
Sub-Investigator: Eman Omran, M.D. | |
Sub-Investigator: Doaa Belal, M.D. |
Principal Investigator: | Abdelmaguid Ramzy, M.D. | Cairo University | |
Study Director: | Eman Omran, M.D. | Cairo University |
Responsible Party: | Abdel-Maguid Ramzy, Professor, Cairo University |
ClinicalTrials.gov Identifier: | NCT03209687 |
Other Study ID Numbers: |
3778 |
First Posted: | July 6, 2017 Key Record Dates |
Last Update Posted: | January 27, 2021 |
Last Verified: | January 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Infertility Menotropins Fertility Agents, Female |
Fertility Agents Reproductive Control Agents Physiological Effects of Drugs |