Clinical trial NCT06537102: Unilateral vs Bilateral Laparoscopic Ovarian Drilling In Clomiphene Citrate Resistant Cases of Polycystic Ovarian Syndrome
Official title: Unilateral Versus Bilateral Laparoscopic Ovarian Drilling In Clomiphene Citrate (CC) Resistant Cases of Polycystic Ovarian Syndrome (PCOS): A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic
Ovarian Drilling
Clomiphene Citrate
Polycystic Ovarian Syndrome
Unilateral
Bilateral
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 130
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the current study is to compare the efficacy of laparoscopic unilateral ovarian drilling with bilateral ovarian drilling in clomiphene citrate resistant cases of polycystic ovarian syndrome in terms of clinical response (regularity of the cycle), change in biochemical parameters, ovulation rate over six months, pregnancy rate within six months.

Detailed description: Polycystic ovary syndrome (PCOS), is considered the most common endocrine disorder in reproductive age in females. Polycystic ovary syndrome (PCOS) is characterized by reproductive and metabolic disturbances. Androgen excess is a hallmark of polycystic ovary syndrome (PCOS), driving many of the phenotypic features

The clinical response to laparoscopic ovarian drilling (LOD) seems to be thermal energy dose-dependent. Two punctures (300 J) per ovary are associated with poor results. Between three and five (450-750 J) punctures per ovary seem to represent the effective thermal dose. The application of six or more (C900 J) punctures per ovary may result in excessive destruction to the ovary and should therefore be discouraged.

Eligibility criteria: Inclusion Criteria:

* Age within 25-35 years.
* Polycystic ovarian syndrome as diagnosed according to modified Rotterdam criteria 2018: oligomenorrhea or amenorrhea; clinical and/or biochemical signs of hyperandrogenism; and transvaginal sonographic appearance of polycystic ovaries (≥ 20 follicles or an ovarian volume 10 cm3) .
* Infertile women who have clomiphene citrate -resistant polycystic ovary syndrome (150 mg/daily for 5 days for six cycles with no ovulation).
* Normal semen analysis in the husband.

Exclusion Criteria:

* Hyper-androgenic disorders like late onset congenital adrenal hyperplasia, hyperprolactinemia, thyroid diseases.
* Cushing's syndrome and androgen-secreting tumors.
* Body mass index \> 30 kg/m2.
* Other medical problems like diabetes, Hypertesion, patients on steroid hormone .... etc.
* Other causes of infertility as multiple uterine fibroids.

Primary outcomes:
measure: Restoration of ovulation
timeFrame: 6 month after operation.
Secondary outcomes:
measure: Folliculometry
timeFrame: 6 month after operation.
measure: Follicle-stimulating hormone (FSH)
timeFrame: 6 month after operation.
measure: Luteinizing hormone (LH)
timeFrame: 6 month after operation.
measure: Anti-müllerian hormone(AMH)
timeFrame: 6 month after operation.
measure: Pregnancy rate
timeFrame: 6 month after operation.
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Sahar Saeed Ahmed Elhalfawy
state: ElGharbia
Study officials:
References: