Clinical trial · Interventional
Unilateral vs Bilateral Laparoscopic Ovarian Drilling In Clomiphene Citrate Resistant Cases of Polycystic Ovarian Syndrome
Unilateral Versus Bilateral Laparoscopic Ovarian Drilling In Clomiphene Citrate (CC) Resistant Cases of Polycystic Ovarian Syndrome (PCOS): A Randomized Controlled Study
NCT06537102CI-TRIAL-00079459completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bilateral | — | UNRESOLVED | — |
| Clomiphene Citrate | — | UNRESOLVED | — |
| Laparoscopic | — | UNRESOLVED | — |
| Ovarian Drilling | — | UNRESOLVED | — |
| Polycystic Ovarian Syndrome | — | UNRESOLVED | — |
| Unilateral | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bilateral laparoscopic ovarian drilling | Other | — | UNRESOLVED |
| Unilateral laparoscopic ovarian drilling | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Unilateral laparoscopic ovarian drilling group
- description
- Patients underwent unilateral laparoscopic ovarian drilling 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.
- interventionNames
- Other: Unilateral laparoscopic ovarian drilling
- type
- OTHER
- label
- Bilateral laparoscopic ovarian drilling group
- description
- 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 e 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 35 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.