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

Cairo University (CU)

Status and phase: Enrolling; Phase 4

Conditions: Infertility

Treatments: Drug: human menopausal gonadotropin

Study type: Interventional

Funder types: Other

Identifiers

NCT03209687

3778

Details and patient eligibility

About

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

Full 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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

600 participants in 2 patient groups

Human menopausal gonadotropin (HMG)

Experimental group

Description:

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

Treatment:

Drug: human menopausal gonadotropin

Routine care

No Intervention group

Description:

This group will receive the routine care for luteal phase support