Dydrogesterone-Primed Ovarian Stimulation Protocol Versus Gonadotropin Releasing Hormone Antagonist Protocol in ICSI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-20

Study Completion Date

2025-03-20

Brief Summary

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GnRH antagonist protocol is currently a good strategy for controlled ovarian stimulation in women with PCOS undergoing IVF/ICSI cycles. Finding a protocol that can be a better alternative will help in improving the success rate of IVF/ICSI cycles

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Detailed Description

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Progesterone has potent restraint on hypothalamus-pituitary-ovarian axis. It acts on unidentified hypothalamic pulse oscillator neurons. In turn, it acts on gonadotropins releasing hormone (GnRH) secreting neurons leading to inhibition of GnRH secretion. This results in inhibition of both luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion from anterior pituitary. The effect of progesterone appears to decrease GnRH pulse frequency which results in slowing down LH pulse frequency and reducing LH plasma concentrations

Conditions

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Ovary Cyst Fertility Issues

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group (A)

will be subjected to progestin primed ovarian stimulation protocol Women in group (A), will be prescribed 20 mg oral dose of dydrogesterone (Duphaston, Abbott) from the 2nd day of the cycle and continued until the trigger day. Transvaginal follicular monitoring will be done for all patients starting the 6th day of cycle.

Group Type EXPERIMENTAL

progestin primed ovarian stimulation protocol

Intervention Type OTHER

progestin primed ovarian stimulation protocol

dydrogesterone (Duphaston, Abbott)

Intervention Type DRUG

20 mg oral dose of dydrogesterone (Duphaston, Abbott)

group (B)

Gonadotropin Releasing Hormone Antagonist Protocol when the size of dominant follicles reaches 12-13 mm, 0.25 mg of cetrotide (Merck-Serono Germany) will be injected subcutaneously daily and continued until the day of trigger shot.

Group Type ACTIVE_COMPARATOR

progestin primed ovarian stimulation protocol

Intervention Type OTHER

progestin primed ovarian stimulation protocol

Cetrotide

Intervention Type DRUG

0.25 mg of Cetrotide (gonadotropin releasing hormone (GnRH) antagonist)

Interventions

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progestin primed ovarian stimulation protocol

Intervention Type OTHER

dydrogesterone (Duphaston, Abbott)

20 mg oral dose of dydrogesterone (Duphaston, Abbott)

Intervention Type DRUG

Cetrotide

0.25 mg of Cetrotide (gonadotropin releasing hormone (GnRH) antagonist)

Intervention Type DRUG

Other Intervention Names

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cetrorelix

Eligibility Criteria

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Inclusion Criteria

1. All patients should be candidates for ICSI.
2. Age between 20-40 years.
3. Body mass index 18-35 kg/m2.
4. Diagnosis of PCOS according to modified Rotterdam's criteria

Exclusion Criteria

* 1\) Any patient with contraindication to IVF treatment or pregnancy 2) Women with history of intra-uterine abnormality. 3) Severe endometriosis (grade 3 or 4) 4) Clinically significant systemic disease or other endocrinopathy.

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No