Can Drospirenone be Used to Prevent LH Surge in Controlle... | NCT06608186

Studies
Can Drospirenone be Used to Prevent LH Surge in Controlled Ovarian Stimulation in PCOS?!

NCT06608186

Sponsor

Ahmed Saad

Status

Completed

Last Update Posted

Jan 22, 2025Actual

Enrollment

50Actual

Phase

Phase 1Phase 2

Conditions

PCOS (Polycystic Ovary Syndrome)

Interventions

Cetrorelix drug
Drospirenone drug

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2024Actual

Primary Completion Date

Jan 19, 2025Actual

Completion Date

Jan 19, 2025Actual

First Submitted Date

Sep 19, 2024

First Submission Date that Met QC Criteria

Sep 20, 2024

First Posted Date

Sep 23, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 19, 2025

Last Update Posted Date

Jan 22, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ahmed Saad, Professor of Obsterics & Gynecology, Benha UniversitySponsor-Investigator

Lead Sponsor

Ahmed SaadOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this clinical trial is to learn if drospirenone can work to prevent LH surge in controlled ovarian stimulation in PCOS cases undergoing ART cycles. The main questions it aims to answer are:

Can drospirenone prevent LH surge in controlled ovarian stimulation in PCOS cases ? Can it prevent the occurance of ovarian hyperstimulation?

Researchers will compare drospirenone to cetrorelix (A well known drug for such cases) to see if drospirenone works the same way.

Participants will:

Take drospirenone or cetrorelix from stimulation day 5 ( 5 days of ovarian stimulation) till day of hCG trigger

- monitoring will be done before the cycle and through the cycles with vaginal ultrasound assessment and lab testing

Detailed Description

The goal of this novel clinical trial is to study if drospirenone can work to prevent LH surge in controlled ovarian stimulation in PCOS cases undergoing ART cycles in comparison to a gold standard drug cetrorelix:

All PCOS cases: 50 case in this novel trial. 25 in each group will be randomized after taking 5 days of ovarian stimulation to either drospirenone tablet/d or cetrorelix injection/d till the day of hCG.

At the day of hCG, lab testing will be done in addition to ultrasound assessment by transvaginal probe. the tests are: progesterone, E2, LH.

Assesment will be done for the number quality of follicles and the number quality of embryos developed, development of OHSS, vitrification/thawing of embryos after 1 month then the clinical and chemical pregnancy rate.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Drospirenone	Experimental	25 cases will receive drospirenone in the form of 1 tablet / d from day 5 of stimulation till hCG trigger day	Drug: Drospirenone drug
cetrorelix	Active Comparator	25 cases will receive cetrorelix from day 5 of stimualtion till hCG trigger day	Drug: Cetrorelix drug

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cetrorelix drug	Drug	a drug injection daily sc. from day 5 of stimulation till hCG trigger day	cetrorelix

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of cases to develop OHSS	cases that will develop OHSS	1 week
number of embryos	number of embryos developed	5 days

Secondary Outcomes

Measure	Description	Time Frame
clinical pregnancy rate	serum pregnancy test after thawing of the embryos and embryo transfer	15 days after embryo transfer

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

PCOS was diagnosed according to the Rotterdam consensus criteria (two out of three of the following criteria):
1. oligo- or anovulation
2. clinical and/or biochemical signs of hyperandrogenism
3. polycystic ovaries).
A diagnosis of congenital adrenal hyperplasia, Cushing's syndrome, androgen-producing tumours, hyperprolactinemia and thyroid dysfunction were all rulled out.

Exclusion Criteria:

age 38 years
basal FSH level 12 mIU/mL
previous ovarian surgery
congenital uterine anomaly anomaly, intrauterine adhesion and male partner with non-obstructive azoospermia.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

female gender phenotypically and genetically

Minimum Age

20 Years

Maximum Age

38 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahmed s saad, phD	Professor of OB & GYN	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hawaa Fertility center		Banhā	Qalyubia Governorate	13512	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

the protocol excel sheet

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

6 months

Access Criteria

6 months

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011085	Polycystic Ovary Syndrome

Ancestor Terms

ID	Term
D010048	Ovarian Cysts
D003560	Cysts
D009369	Neoplasms
D010049	Ovarian Diseases
D000291

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C062876	cetrorelix
C534342	drospirenone and ethinyl estradiol combination

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

50 case in this novel trial. 25 in each group will be randomized after taking 5 days of ovarian stimulation to either drospirenone tablet/d or cetrorelix injection/d till the day of hCG.