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NCT Number: NCT06537102

Unilateral vs Bilateral Laparoscopic Ovarian Drilling In Clomiphene Citrate Resistant Cases of Polycystic Ovarian Syndrome

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.

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Key information

Conditions

Laparoscopic Adnexal Diseases Bilateral Clomiphene Citrate Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Ovarian Drilling Polycystic Ovarian Syndrome Polycystic Ovary Syndrome Unilateral Urogenital Diseases

Age range

25 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sahar Saeed Ahmed Elhalfawy

Tanta, ElGharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Unilateral laparoscopic ovarian drilling

Other

Laparoscopic drilling was performed under general anesthesia as follows: 10-mm subumbilical entry and two 5-mm secondary ports in the lower part of the abdomen just above the anterior superior iliac spine. The laparoscope is introduced through the subumbilical port, and secondary ports was used for introduction of the instruments, the type of needle was an insulated unipolar needle electrode with a non-insulated distal end. We are planning to use the least thermal effective dose which is 60 J/cm3 of ovarian tissue.

The number of punctures (Np) per ovary was calculated according to the following formula: N p = 60 J/cm3/40 W × 4 s, with 3 mm diameter and 4 mm depth for each puncture using power setting of 300 W for 2-4 s. Unilateral: was done on the larger ovary.

Bilateral laparoscopic ovarian drilling

Other

Laparoscopic drilling was performed under general anesthesia as follows: 10-mm subumbilical entry and two 5-mm secondary ports in the lower part of the abdomen just above the anterior superior iliac spine. The laparoscope is introduced through the subumbilical port, and secondary ports was used for introduction of the instruments, the type of needle was an insulated unipolar needle electrode with a non-insulated distal end. We are planning to use the least thermal effective dose which is 60 J/cm3 of ovarian tissue.

The number of punctures (Np) per ovary was calculated according to the following formula: N p = 60 J/cm3/40 W × 4 s, with 3 mm diameter and 4 mm depth for each puncture using power setting of 300 W for 2-4 s. Bilateral: Using dose adjusted according to ovarian volume.

Primary outcomes

  1. Restoration of ovulation

    Time frame: 6 month after operation.

    Restoration of ovulation was measured before operation and for 6 month after operation .

Secondary outcomes

  1. Folliculometry

    Time frame: 6 month after operation.

    Folliculometry was measured before operation and for 6 month after operation .

  2. Follicle-stimulating hormone (FSH)

    Time frame: 6 month after operation.

    Follicle-stimulating hormone (FSH) was measured before operation and for 6 month after operation .

  3. Luteinizing hormone (LH)

    Time frame: 6 month after operation.

    Luteinizing hormone (LH) was measured before operation and for 6 month after operation .

  4. Anti-müllerian hormone(AMH)

    Time frame: 6 month after operation.

    Anti-müllerian hormone(AMH) was measured before operation and for 6 month after operation .

  5. Pregnancy rate

    Time frame: 6 month after operation.

    Pregnancy rate was measured before operation and for 6 month after operation .

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Unilateral Versus Bilateral Laparoscopic Ovarian Drilling In Clomiphene Citrate (CC) Resistant Cases of Polycystic Ovarian Syndrome (PCOS): A Randomized Controlled Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 5, 2024
Registry last updated
Aug 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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