Double Trigger in Patients With Low Number of Oocytes Retrieved Per Number of Preovulatory Follicles

Infertility, Female Clinical Trial

Official title:

Double Trigger in Patients With Low Number of Oocytes Retrieved Per Number of Preovulatory Follicles. A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04407065
• Other study ID #: Double trigger/more oocytes
• Status: Recruiting
• Phase: Phase 2
• Start date: May 30, 2020
• Est. completion date: February 2, 2021

Study information

• Verified date: May 2020
• Source: Riyadh Fertility and Reproductive Health center
• Contact: Usama M Fouda, Prof.
• Phone: +201095401375
• Email: umfrfouda[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this randomized controlled trial is to determine whether co-administration of GnRH agonist and hCG for final oocyte maturation ( 40 and 34 h prior to oocyte retrieval , respectively) can increase the oocytes yield in patients with history of poor oocytes yield, despite normal response to COH, due to low (<50%) number of oocytes retrieved per number of follicles > 14 mm in diameter on day of hCG administration

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: February 2, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Patients with history of poor oocytes yield in previous IVF attempt, despite normal response to COH, due to low (<50%) number of oocytes retrieved per number of follicles > 14 mm in diameter on day of hCG administration

• Patients with 6 to 15 mature follicles on the day oocyte trigger in the current IVF-ET attempt

Exclusion Criteria:

• Endometriosis

• PCOS

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Drug:
• Double trigger
Final follicular maturation is triggered by the co-administration of GnRH-agonist (Triptorelin acetate, decapeptyl 0.2 mg, Slough, United Kingdom) and 10000 IU of HCG, 40 and 34 h prior to oocyte retrieval, respectively
• HCG trigger
Final follicular maturation is triggered by a dose of 10000 IU of HCG 36 h prior to oocyte retrieval

Locations

Country	Name	City	State
Egypt	Riyadh Fertility and Reproductive Health center	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Riyadh Fertility and Reproductive Health center

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Haas J, Zilberberg E, Dar S, Kedem A, Machtinger R, Orvieto R. Co-administration of GnRH-agonist and hCG for final oocyte maturation (double trigger) in patients with low number of oocytes retrieved per number of preovulatory follicles--a preliminary report. J Ovarian Res. 2014 Aug 2;7:77. doi: 10.1186/1757-2215-7-77. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of oocytes retrieved		First day after oocyte retrieval
Secondary	clinical pregnancy rate	The presence of gestational sac detected by ultrasound examination	First 5 weeks after oocyte retrieval