Metformin for the Treatment of Unexplained Oligozspermia

The Egyptian IVF-ET Center

Status and phase: Unknown; Phase 4

Conditions: Infertility

Treatments: Drug: Clomiphene citrate / hCG; Drug: Metformin / clomid / hCG

Study type: Interventional

Funder types: Other

Identifiers

NCT01529177

metformin for spermatogenesis

Details and patient eligibility

About

Insulin resistance (IR) in men may be the underlying pathogenesis for metabolic abnormalities and chronic hypospermatogenesis similar to women with polycystic ovarian disease (PCOD). Infertile men with unexplained infertility and IR may benefit from treatment with metformin.

Full description

Recently insulin resistance (IR) has been recognized as the underlying pathogenesis of chronic anovulation, hyperandrogenism, and metabolic abnormalities associated with PCOD in women. IR could be the underlying pathogenesis of chronic hypospermatogenesis leading to oligospermia and azoospermia associated with other metabolic abnormalities in men. Metformin has proven as an effective medication for not only IR but several other aspects of the PCOD including reproductive abnormalities. Therefore, insulin sensitizers, particularly metformin can be introduced as a pharmaceutical option for unexplained oligozoospermia and azoospermia associated with insulin resistance.

Enrollment: 600 estimated patients

Sex: Male

Ages: 25 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• oligospermia ( < 10 million per mil-litter )
• normal FSH
• high insulin

Exclusion criteria

• abnormal karyotype
• obstructive azoospermia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Metformin / clomid / hCG

Experimental group

Description:

Metformin 1000 mg orally to be given daily for one week then twice daily for 2 weeks then 3 times daily for 6 months. After 3 months from starting metformin the participant will receive 2 more medications in addition to metformin: Clomid 50 mg orally per day and 5000 IU human chorionic gonadotrophin (hCG ) IM once per week for three months.

Treatment:

Drug: Metformin / clomid / hCG

Clomid / hCG

Experimental group

Description:

Clomid 50 mg per day will be administered orally and human chorionic gonadotrophin ( choriomon ) 5000 IU will be administered IM once per week. Both medications will be given for 6 month.

Treatment:

Drug: Clomiphene citrate / hCG