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

Comparison Between Effects of Dydrogesterone, Cetrorelix Acetate and Triptorelin on Intra Cytoplasmic Sperm Injection Outcomes

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.

Study Overview

• Status: Recruiting
• Conditions: IVF
• Intervention / Treatment: Drug: Triptorelin; Drug: Dydrogesterone; Drug: Cetrorelix acetate

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.

• Study Type: Interventional
• Enrollment (Estimated): 387
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Beni Suef
    • Banī Suwayf, Beni Suef, Egypt, 62521
      • Recruiting
      • Beni-suef university Hospital
      • Contact: Beni Suef University; Phone Number: 2 082 2356845; Email: info@bsu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dydrogesterone; For pituitary suppression, the patients receives Dydrogesterone (Duphaston 10 mg/twice daily, Abbott Healthcare, America) orally since day 2-3.	Drug: Dydrogesterone; Dydrogesterone molecular structure and pharmacologic effects are closely related to endogenous progesterone; Other Names: Duphaston
Active Comparator: 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.	Drug: Cetrorelix acetate; GnRH antagonist; Other Names: cetrotide
Active Comparator: 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	Drug: Triptorelin; GnRH agonist; Other Names: Decapeptyl, sc 0.1 mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of oocytes retrieved.	number of oocytes	1cycle (1 month)
maturity of oocytes retrieved.	either M2 or M1	1 cycle (1month)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of stimulation	days till trigger	1 ICSI cycle (1 month)

Collaborators and Investigators

• Sponsor: Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: July 25, 2023
• First Submitted That Met QC Criteria: August 1, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Dydrogesterone; Intra Cytoplasmic Sperm Injection
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Fertility Agents, Female; Fertility Agents; Luteolytic Agents; Progestins; Triptorelin Pamoate; Cetrorelix; Dydrogesterone
• Other Study ID Numbers: Dydrogesterone IVF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No