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CompletedNCT00220545Updated May 9, 2024

Comparison Between Laparoscopic Ovarian Diathermy and Clomiphene Citrate in Women With Anovulatory PCOS

An interventional study of Laparoscopic ovarian diathermy in Polycystic Ovary Syndrome, sponsored by Sheffield Teaching Hospitals NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to female participants aged 19 Years to 39 Years. Per ClinicalTrials.gov, last updated 2024-05-09.

Sponsored by Sheffield Teaching Hospitals NHS Foundation Trust · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
19 Years to 39 Years
Sex
Female
01

Study summary

Laparoscopic ovarian diathermy (LOD) is currently offered to infertile women with polycystic ovarian syndrome (PCOS) who fail to conceive on clomiphene citrate (CC). However, using LOD before CC may result in a better reproductive outcome since LOD may reduce risks associated with CC such as miscarriages and multiple pregnancies. The aim of the study is to evaluate the effectiveness of LOD and its potential value in improving the success rates in infertile women with PCOS. This study will recruit 72 women with PCOS suffering from infertility due to lack of ovulation from the infertility clinic. After initial assessment, patients will be given explanation about the study and will receive an information leaflet. They will then be randomized into two groups: Group1 (36 patients) will receive CC as per infertility clinic protocol to induce ovulation for up to 6 months. Group 2 (36 patients) will undergo laparoscopic ovarian diathermy under general anaesthetic. Blood samples will be taken from both groups before any treatment, shortly after treatment and at 3 and 6 months after treatment to measure various hormones. Patients will be contacted every month after treatment for follow up. The reproductive outcomes particularly the pregnancy and livebirth rates will be compared between the two groups.

02

Conditions studied

  • Polycystic Ovary Syndrome

Keywords

  • Polycystic ovarY
  • Laparoscopic ovarian diathermy
  • Induction of ovulation
  • Clomiphene citrate
03

In context

Polycystic Ovary Syndrome

975 studies on the registry are indexed under Polycystic Ovary Syndrome; 177 are open to participants now.

This study's planned enrollment of 72 is close to the median of 70 across 710 interventional studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust is the lead sponsor of 213 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 39 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age: 19 - 39
  2. BMI \< 32
  3. Anovulatory Infertility > 1 year
  4. Diagnostic criteria for
  5. No previous treatment for induction of ovulation
  6. Normal semen analysis of partner
  7. Proven patency of at least one Fallopian tube

Exclusion criteria

Exclusion Criteria:

  1. Inability to give informed consent
  2. Contraindication to CC
  3. Contraindication to general anaesthetic or laparoscopy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
72 participants (estimated)

Interventions

  • ProcedureLaparoscopic ovarian diathermy
06

What researchers measure

Primary outcomes

  1. Pregnancy rates

Secondary outcomes

  1. Ovulation, Pregnancy outcome (especially miscarriage), Menstrual pattern, Endocrine changes, Side effects / complications rate

07

Study locations

1 site
  • Jessop Wing, Sheffield Teaching Hospitals NHS Foundation Trust
    Sheffield, South Yorkshire S10 2SF, United Kingdom
08

References and documents

Publications

  • Amer SA, Li TC, Metwally M, Emarh M, Ledger WL. Randomized controlled trial comparing laparoscopic ovarian diathermy with clomiphene citrate as a first-line method of ovulation induction in women with polycystic ovary syndrome. Hum Reprod. 2009 Jan;24(1):219-25. doi: 10.1093/humrep/den325. Epub 2008 Sep 14. PubMed 18794162 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2002 and a completion of Mar 2006. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 14, 2005
First posted
Sep 22, 2005
Start
Mar 2002
Completion
Mar 2006
Last update
May 9, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
No changes since tracking began. The registry record was last updated on May 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00220545
Collaborators
University of Sheffield
Responsible party
Sponsor
First posted
Sep 22, 2005
Start date
Mar 2002
Completion
Mar 2006
Last update
May 9, 2024

Study contacts

Saad AK Amer, MD
principal investigator · University of Sheffield
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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