Triggering Oocyte Maturation in Normoresponders Using Double Trigger or HCG Trigger

Infertility Clinical Trial

— Doubtrig  

Official title:

Triggering Oocyte Maturation in Normoresponders Using Double Trigger or HCG Trigger . A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06146413
• Other study ID #: Double trigger in IVF
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 30, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: November 2023
• Source: Bedaya Hospital
• 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 study is to compare the efficacy double trigger [ co-administration of GnRH agonist with HCG 40 and 34 h prior to ovum pick-up, respectively] with HCG trigger in inducing oocyte maturation.

Description:

Several studies revealed that the double trigger regimen was effective in the treatment of patients with a history of immature oocytes retrieved or with suboptimal oocytes yield.

The investigators designed this randomized controlled trial to compare the efficacy double trigger with HCG trigger in inducing oocyte maturation.in normoreponders undergoing IVF-ET

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 30, 2025
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Normoresponders

• GnRH antagonist cycles

Exclusion Criteria:

• BMI more than 35

• Endometriosis

• AMH less than 1.1 ng

• AMH more than 4

• PCOS

• Poor responders

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Double trigger
GnRH agonist ( Triptorelin ) ( 0.2 mg / S.C ) and hCG ( 10000 IU) are administered 40 and 34 h before ovum pick-up
• HCG trigger
hCG ( 10000 IU) is administered 36 h before ovum pick-up

Locations

Country	Name	City	State
Egypt	Bedaya Hospital	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Bedaya Hospital

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	Metaphase-II oocytes rate	Number of MII oocyte/ number of cumulus oocyte complex	Ten to fifteen days after starting ovarian stimulation
Secondary	Clinical pregnancy rate	Presence of intrauterine gestational sac detected by transvaginal ultrasound	5 weeks after embryo transfer
Secondary	Ongoing Pregnancy Rate	Pregnancies continued beyond 20 weeks gestation	18 weeks after embryo transfer