NCT03664050

Brief Summary

The aim of this work is to compare the clinical outcomes of letrozole with laparoscopic ovarian drilling (LOD) in patients with clomiphene-citrate-resistant polycystic ovary syndrome (PCOS).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 10, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

September 10, 2018

Status Verified

September 1, 2018

Enrollment Period

11 months

First QC Date

September 7, 2018

Last Update Submit

September 7, 2018

Conditions

Induction of Ovulation

Keywords

letrozollaparoscopic ovarian drilling

Outcome Measures

Primary Outcomes (1)

  • OVULATION RATE

    SERUM PROGESTERON LEVEL

    7 DAYS BEFORE NEXT MENSES

Secondary Outcomes (2)

  • BIOCHEMICAL PREGNANCY RATE

    AFTER 30 DAYS OF INTERVENTION

  • CLINICAL PREGNANCY RATE

    AT 6 WEEKS GESTATION

Study Arms (2)

Group A Letrozole group

EXPERIMENTAL

2.5 mg letrozole oral tablets will be administered on the 2nd -3rd day of menses and then every day for 5 days.

Drug: group A 2.5 mg letrozole oral tablets

Group B laparoscopic ovarian drilling group

ACTIVE COMPARATOR

bilateral laparoscopic ovarian drilling, each ovary will be cauterized at 4 points, each for 4 sec at 40 W, at a depth of 7-8 mm and a diameter of 3-5 mm, using a monopolar electrosurgical needle according to the size of each ovary.

Procedure: laparoscopic ovarian drilling

Interventions

group A 2.5 mg letrozole oral tabletsDRUG

2.5 mg letrozole oral tablets will be administered on the 2nd-3rd day of menses and then every day for 5 days. Treatment will be repeated for up to three cycles if the patient failed to conceive.

Group A Letrozole group
laparoscopic ovarian drillingPROCEDURE

Bilateral laparoscopic ovarian drilling, each ovary will be cauterized at 4 points, each for 4 sec at 40 W, at a depth of 7-8 mm and a diameter of 3-5 mm, using a monopolar electrosurgical needle according to the size of each ovary.

Group B laparoscopic ovarian drilling group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients diagnosed as PCOS according to Roterdam (2003) criteria
  • patients with Clomiphene resistance, i.e. failure to ovulate following 100 mg CC for 5 days for at least three cycles.
  • patent fallopian tubes, confirmed by hysterosalpingography or hysteroscopic diagnosis.
  • normal semen analysis parameters of the patients' spouses according to the modified criteria of the World Health Organization.
  • normal serum prolactin, thyroid stimulating hormone and 17-OH progesterone.
  • no systemic disease; no gonadotropin or other hormonal drug treatment during the preceding 3 months.

You may not qualify if:

  • Infertility induced by reasons other than PCOS. 2- uterine cavity lesions or ovarian cyst. 3- \>40 years old. 4- body mass index (BMI) \>26 kg/m2. 5- contraindications to general anesthesia. 6- history of pelvic surgery. 7- other endocrine diseases. 8- a history of liver or kidney disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams university maternity hospital

Cairo, 25187, Egypt

RECRUITING

Related Publications (1)

  • Franik S, Le QK, Kremer JA, Kiesel L, Farquhar C. Aromatase inhibitors (letrozole) for ovulation induction in infertile women with polycystic ovary syndrome. Cochrane Database Syst Rev. 2022 Sep 27;9(9):CD010287. doi: 10.1002/14651858.CD010287.pub4.

    PMID: 36165742DERIVED

MeSH Terms

Interventions

Letrozole

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Ahmed Abdelshafy, MD

CONTACT

00201223266380ahmedshafy@hotmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 7, 2018

First Posted

September 10, 2018

Study Start

January 1, 2018

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

September 10, 2018

Record last verified: 2018-09

Locations

EG(1)