NCT05699356

Brief Summary

The study will focus on treatment of Poly Cystic Ovary Syndrome patients with infertility The aim is to to find the best treatment by comparison of surgical and non surgical intervention

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
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

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

October 11, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2023

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2023

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

October 18, 2022

Last Update Submit

January 25, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • The rate of ovulation after life modification

    The study will focus on different methods of health modification like health eating, exercise and weight loss and their ability to keep hormones in normal ranges and cause ovulation

    6 months

  • Rate of ovulation by medical treatment like Clomifene Citrate and Letrozole

    The study also will focus on different medical treatment method like Clomifene Citrate, lentrozole for induction in ovulation

    6 months

  • Rate of regular ovulation after laparoscopic Ovarian drilling (Surgical treatment)

    The surgery is done to remove part of ovary through laparoscopy which results ovary to restore normal ovulation

    6 months

Study Arms (6)

Surgical treatment of Poly cystic ovary for infertility by laparoscopic drilling

laparoscopic drilling response in Poly Cystic Ovary case

Procedure: laparoscopic drilling

Non-surgical treatment of Poly cystic ovary for infertility

induction,Anti estrogen,Insulin sensitizing agent, Aromatase Inhibitor,Gonadotropin

Other: Non Surgical treatment

Treatment of Poly cystic ovary for infertility by Life style modification

Life style modification response in Poly Cystic Ovary case for treatment of infertility

Behavioral: Treatment of Poly cystic ovary for infertility by Life style modification

Treatment of Poly cystic ovary for infertility by Assisted reproductive technique

Assisted reproductive technique response in Poly Cystic Ovary case for treatment of infertility

Procedure: Treatment of Poly cystic ovary for infertility by Assisted reproductive technique

Treatment of Poly cystic ovary for infertility by controlling menstrual disorders

Controlling menstrual disorders response in Poly Cystic Ovary case for treatment of infertility

Other: Non Surgical treatment

Treatment of Poly cystic ovary for infertility by Cutaneous manifestation

Cutaneous manifestation response in Poly Cystic Ovary case for treatment of infertility

Other: Non Surgical treatment

Interventions

Non Surgical

Also known as: Induction, Aromatase inhibitor,Insulin sensitizing agent,Gonadotropin,Anti estrogen
Non-surgical treatment of Poly cystic ovary for infertilityTreatment of Poly cystic ovary for infertility by Cutaneous manifestationTreatment of Poly cystic ovary for infertility by controlling menstrual disorders

Surgical intervension

Surgical treatment of Poly cystic ovary for infertility by laparoscopic drilling

Non Surgical

Also known as: Non surgical treatment option
Treatment of Poly cystic ovary for infertility by Life style modification

Surgical intervention

Also known as: Surgical treatment option
Treatment of Poly cystic ovary for infertility by Assisted reproductive technique

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemales on child bearing age
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women in a child bearing age with poly cystic ovarian syndrome

You may qualify if:

  • Infertility cases with Poly Cystic Ovary sundrome

You may not qualify if:

  • Infertility cases not related with Poly cystic ovary

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suhag University hospital

Sohag, Egypt

RECRUITING

Related Links

MeSH Terms

Interventions

Neoadjuvant TherapyAromatase Inhibitors

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsSteroid Synthesis InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesEstrogen AntagonistsHormone AntagonistsHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of Drugs

Central Study Contacts

Hawala S Mohammed, Resident

CONTACT

Yasser A Helmy, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

October 18, 2022

First Posted

January 26, 2023

Study Start

October 11, 2022

Primary Completion

March 20, 2023

Study Completion

March 28, 2023

Last Updated

January 26, 2023

Record last verified: 2023-01

Locations