The Value of Addition of Human Menopausal Gonadotropin Drug Following Oocytes Retrieval in IVF Cycles

Human Menopausal Gonadotropin as a Novel Addition to Luteal Phase Support in Down-regulated ICSI Cycles (RCT)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03209687

Enrollment

600

Registered

2017-07-06

Start date

2017-07-06

Completion date

2024-08-15

Last updated

2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Brief summary

The aim of this study is to test the hypothesis that addition of daily small dose of human menopausal gonadotropin (HMG) drug following oocytes retrieval could improve the fertility outcome in women undergoing in-vitro fertilization

Detailed description

The study will be conducted in the IVF unit of Cairo University. Females undergoing ICSI cycles in the age between 20 and 40 years will be allocated to one of 2 groups. Long agonist protocol will be used. Allocation to either one of 2 groups will be done on the day of oocytes retrieval. The first group will take (in addition to the routine care) daily human menopausal gonadotropin drug injection for 2 weeks. The second group will receive the routine care.

Interventions

DRUGhuman menopausal gonadotropin

Merional injections will be given to participants after ovum pickup in in-vitro fertilization cycles

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 40 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Live birth rate	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

Secondary

Measure	Time frame	Description
Clinical pregnancy rate	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	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	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

Countries

Egypt

Contacts

PRINCIPAL_INVESTIGATORAbdelmaguid Ramzy, M.D.

Cairo University

STUDY_DIRECTOREman Omran, M.D.