Dydrogesterone, Cetrorelix Acetate and Triptorelin in Intra Cytoplasmic Sperm Injection Outcomes

NCT ID: NCT05972902

Last Updated: 2023-08-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 387 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-15
• Study Completion Date: 2023-12-31

Brief Summary

To compare the effects of Duphaston compared to GnRH agonist and antagonist on the prevention of premature LH surge and quality of retrieved oocytes and embryos in women undergoing intra-cytoplasmic sperm injection.

Detailed Description

Study Design:

A randomized clinical trial (RCT).

Study Site:

The study will be conducted at Beni-Suef University Hospital Assisted Reproductive Techniques center. The study population includes all infertile women undergoing IVF at Beni-Suef University ART center will be included. Women will be recruited for enrollment when they come to fertility clinic and scheduled for ICSI trial. They will be counseled and asked to participate in the study after been evaluated to ensure fulfilling inclusion and exclusion criteria.

Study Sample:

The study consisted of 387 women which will be randomized into 3 groups. Women will be enrolled in the study after giving written informed consent. Group (A): 129 Women will start Dydrogesterone group. Group (B): 129 Women will undergo Agonist protocol group. Group (c): 129 Women will undergo Antagonist protocol group.

Study Procedure:

Full history taking. Systematic clinical examination to assess the general condition, body mass index (BMI) and local pelvic physical findings and AFC by trans-vaginal ultrasound on D2 to 3 of menstruation. Routine labs as CBC, liver & kidney functions to exclude general disease as a contraindication for induction or pregnancy. Blood sample obtained for assessment of basal serum levels of FSH, LH, PRL, AMH and E2 on day 3 of the cycle.

Ovarian Stimulation:

#Treatment protocols: The patients begins injections of recombinant FSH (rFSH, Gonal-F; Merck- Serono, Italy) or human menopausal gonadotropin (hp-hMG, Menopur; Ferring Pharmaceuticals, Geneva,Switzerland) since day 2-3 of menstruation, with daily dose of 150-450 IU adjusted according to individual conditions on the basis of the antral follicle count (AFC), age of the woman, body mass index (BMI), and previous ovarian response, according to the standard operating procedures of the center.

For pituitary suppression, the patients received:

• Dydrogesterone (Duphaston 10 mg/twice daily, Abbott Healthcare, America) orally since day 2-3.
• GnRH antagonist (CETROTIDE 0.25MG , MERCK SERONO, Germany) 0.25 mg/day subcutaneously since the dominant follicles reached the diameter of 12-14 mm till trigger day.
• GnRH agonist (Decapeptyl, sc 0.1 mg/day) beginning in the afternoon of the 21st day of the cycle prior to stimulation. The serum LH, estradiol and progesterone levels as well as number and size of follicles will be monitored every 1 to 2 days, starting from stimulation day 5 until the day of hCG injection. The daily dose of rFSH will be adjusted according to patient' s ovarian response, based on serum estradiol levels and the number and size of ovarian follicles as measured by transvaginal ultrasonography.

Triggering and Ovum pick uptake:

Triptorelin (0.2 mg; Decapeptyl, Ferring Pharmaceuticals, the Netherlands) or human chorionic gonadotropin (10000 IU; Choriomon) or Ovitrel 250 mg (Merck Serono, Italy) are given to trigger final maturation of the oocytes. Oocyte retrieval was performed approximately 36 hours later.

Fresh and Frozen Embryo Transfer:

A maximum of 2 embryos will be transferred on day 3 after retrieval under transabdominal ultrasound guidance. Day 3 -5 embryos in the antagonist group and all the viable embryos or blastocysts in the duphaston group are cryopreserved using vitrification.

Conditions

IVF

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dydrogesterone

For pituitary suppression, the patients receives Dydrogesterone (Duphaston 10 mg/twice daily, Abbott Healthcare, America) orally since day 2-3.

Group Type: EXPERIMENTAL

Dydrogesterone

Intervention Type: DRUG

Dydrogesterone molecular structure and pharmacologic effects are closely related to endogenous progesterone

GnRH antagonist

For pituitary suppression, the patients receives GnRH antagonist (CETROTIDE 0.25MG , MERCK SERONO, Germany) 0.25 mg/day subcutaneously since the dominant follicles reached the diameter of 12-14 mm till trigger day.

Group Type: ACTIVE_COMPARATOR

Cetrorelix acetate

Intervention Type: DRUG

GnRH antagonist

GnRH agonist

For pituitary suppression, the patients receives (Decapeptyl, sc 0.1 mg/day) beginning in the afternoon of the 21st day of the cycle prior to stimulation

Group Type: ACTIVE_COMPARATOR

Triptorelin

Intervention Type: DRUG

GnRH agonist

Interventions

Dydrogesterone

Dydrogesterone molecular structure and pharmacologic effects are closely related to endogenous progesterone

Intervention Type: DRUG

Cetrorelix acetate

GnRH antagonist

Intervention Type: DRUG

Triptorelin

GnRH agonist

Intervention Type: DRUG

Other Intervention Names

Duphaston; cetrotide; Decapeptyl, sc 0.1 mg/day

Eligibility Criteria

Inclusion Criteria

• Having indications for ICSI.

Exclusion Criteria

1. Any known contraindications to the approved fertility drugs.

2. Severe endometriosis.

3. Uterine malformations or abnormal uterine cavity.

4. Uncontrolled endocrinopathies: DM, hyperthyroidism, hypothyroidism.

5. Severe male factor for infertility.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Sara Abdallah Mohamed Salem

Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beni-suef university Hospital

Banī Suwayf, Beni Suweif Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Beni Suef University

Role: primary

info@bsu.edu.eg

082 2356845 ext. 2

Other Identifiers

Dydrogesterone IVF

Identifier Type: -

Identifier Source: org_study_id