LOD vs Gn in Anovulatory PCOs Resistant to First Line Agents

Assiut University

Status: Unknown

Conditions: Polycystic Ovary Syndrome; Anovulation

Treatments: Drug: Recombinant FSH (rFSH); Procedure: Laparoscopic ovarian drilling

Study type: Interventional

Funder types: Other

Identifiers

NCT04325295

induction resistant PCOs

Details and patient eligibility

About

PCOS is a complex disease that is diagnosed by the presence of two of the following three: oligo/anovulation, clinical and/or biochemical hyperandrogenism, or polycystic ovaries by ultrasound . PCOS affects 4% to 21% of females in reproductive age . Although subfertility is abundant in women with PCOS, a majority of these women will achieve pregnancy naturally or by treatment.

Different treatment modalities are present for ovulation induction. Life style modifications including weight loss are encouraged for those who are overweight or obese. Pharmacological induction of ovulation represent the first line therapy for induction of ovulation. Options include aromatase inhibitors (Letrozole), Clomiphene Citrate (CC) or Metformin, alone or in combinations.

For second line treatment either Gonadotropins (Gn) or laparoscopic ovarian surgery (LOS) are the recommended options .

the objective of the trial is to study the effectiveness and safetey of surgical induction of ovulation strategy and compare it to medical induction strategy with Gonadotropins

Full description

PCOS is a complex disease that is diagnosed by the presence of two of the following three: oligo/anovulation, clinical and/or biochemical hyperandrogenism, or polycystic ovaries by ultrasound . PCOS affects 4% to 21% of females in reproductive age . Although subfertility is abundant in women with PCOS, a majority of these women will achieve pregnancy naturally or by treatment.

Different treatment modalities are present for ovulation induction. Life style modifications including weight loss are encouraged for those who are overweight or obese. Pharmacological induction of ovulation represent the first line therapy for induction of ovulation. Options include aromatase inhibitors (Letrozole), Clomiphene Citrate (CC) or Metformin, alone or in combinations.

For second line treatment either Gonadotropins (Gn) or laparoscopic ovarian surgery (LOS) are the recommended options .

Systematic reviews done comparing LOD to Gn found no differences in live birth, clinical pregnancy or miscarriage rates. However, there was significant decrease in OHSS and multiple pregnancies with LOD . Giving these advantages together with being cheap, the surgical strategy may be a more favorable choice as second line treatment of anovulation . Also several randomised controlled trial (RCTs) reported normalization of ovarian reserve parameters after LOD, making it a long-lasting option compared to the one-cycle effect of medical treatment the objective of the trial is to study the effectiveness and safetey of surgical induction of ovulation strategy and compare it to medical induction strategy with Gonadotropins

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

anovulatory polycystic ovary syndrome resistant to first line ovulation induction.

• Polycystic ovary Syndrome defined by Rotterdam's criteria 2003
• Clomiphene resistance defined as failure to ovulate with a dose of 150mg per day for 5 days for 3 cycles
• Letrozole resistance defined as failure to ovulate with a dose of 7.5 mg per day for 5 days for 3 cycles

Exclusion criteria

• women's age < 18 years or ≥ 40 years.
• BMI > 40 kg/m2
• Patient with hyperprolactinaemia (serum prolactin above normal limits)
• Patients with hypogonadotropic hypogonadism (low serum FSH and LH)
• Patients with anovulation due to ovarian failure (serum FSH higher than normal limits)
• Male infertility
• Tubal abnormality, Known endometriosis, adenomyosis, uterine myomas or any other detected cause of female infertility
• History of ovarian surgery as laparoscopic ovarian drilling, ovarian cystectomy or oophorectomy
• History of pelvic radiation
• Patient recently treated with any type of induction of ovulation in the last three months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Surgical treatment strategy:

Active Comparator group

Treatment:

Procedure: Laparoscopic ovarian drilling

Gonadotrophins treatment strategy

Active Comparator group

Treatment:

Drug: Recombinant FSH (rFSH)