Long Protocol and Growth Hormone in Poor Responders

Woman's Health University Hospital, Egypt

Status and phase: Completed; Phase 2

Conditions: Infertility

Treatments: Drug: Growth hormone

Study type: Interventional

Funder types: Other

Identifiers

NCT02338206

LP112015

Details and patient eligibility

About

The long down regulation protocol is widely used in the in vitro fertilization cycles, now it will be assessed regarding its efficacy, in poor responder females undergoing in vitro fertilization cycles, alone and after the addition of growth hormone.

Enrollment: 240 patients

Sex: Female

Ages: 20 to 44 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Poor responder females are those who posses two out of these three criteria:
• Female age ≥40 years
• Females who have at least one previous cancelled IVF cycle
• POR according to AFC ≤ 5 or low AMH value.

Exclusion criteria

• Females over 45 years
• Females with FSH more than 20 IU/l
• Females with previous ovarian surgery
• Females suffering from causes of infertility other than poor ovarian response
• Females refusing to be enrolled in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Long + Growth hormone

Active Comparator group

Description:

Patients in this group were given a long protocol of pituitary down-regulation with triptorelin (Decapeptyl; Ferring, Switzerland) starting on the day 21 of preceding cycle at a dose of 0.1 mg/day, subcutaneously along with Growth hormone (Norditropin, Novo nordisk) co-treatment daily in a dose of 2.5 mg S.C. till the day of hCG administration.. On the second day of menstruation, Human menopausal gonadotrophin HMG (75 IU, Merional, IBSA) was started, and this was associated with reduction of triptorelin dose to 0.05 mg/day. This reduced daily dose, in addition to HMG and growth hormone, were continued till the day of hCG administration.

Treatment:

Drug: Growth hormone

Long protocol only

No Intervention group

Description:

Patients in this group were given a long protocol of pituitary down-regulation with triptorelin (Decapeptyl; Ferring, Switzerland) starting on the day 21 of preceding cycle at a dose of 0.1 mg/day, subcutaneously. On the second day of menstruation, Human menopausal gonadotrophin HMG (75 IU, Merional, IBSA) was started, and this was associated with reduction of triptorelin dose to 0.05 mg/day. This reduced daily dose, in addition to HMG, were continued till the day of hCG administration.