The Effect of a Dual Trigger on Intracytoplasmic Sperm Injection (ICSI) Reproductive Outcomes

Pregnancy Clinical Trial

Official title:

Dual Trigger With Gonadotropin-releasing Hormone Agonist (GnRHa) and Human Chorionic Gonadotropin (hCG) to Optimize ICSI Reproductive Outcomes

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01979341
• Other study ID #: AntalyaIVF-RCT-dual trigger
• Secondary ID: App. No. 0104201
• Status: Withdrawn
• Phase: N/A
• First received: November 1, 2013
• Last updated: May 25, 2016
• Start date: October 2013
• Est. completion date: September 2016

Study information

• Verified date: May 2016
• Source: Antalya IVF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The use of antagonist controlled ovarian stimulation protocols has allowed the use of GnRH agonist to be used for final oocyte maturation. The use of GnRH agonist as ovulation trigger has been shown to reduce the risks for ovarian hyperstimulation syndrome (OHSS), but its sole use results in reduced embryo implantation due to luteal phase insufficiency. The combination of GnRH agonist and variable doses of hCG for final oocyte maturation has been shown to overcome the luteal phase insufficiency effecting endometrial receptivity.

In this study the investigators will test the hypothesis that using GnRH agonist (0.2mg Triptorelin) and a full dose of hCG (6500IU Ovitrelle) for final oocyte maturation in normoresponders will increase oocyte maturity, embryo quality and embryo implantation and reduce ovarian hyperstimulation syndrome, as compared to the traditional hCG (full dose) alone trigger.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• Age; < 40 years

• Cycle number; cycles 1 or 2

• Antral follicle count; >10 and <25

• BMI; >18 and <30

• Normogonadotrophic cycle length; 24 to 25 days

• Male; ejaculated semen only

Exclusion Criteria:

• Presence of endocrine disorders; (diabetes mellitus, hyperprolactinemia, thyroid dysfunction, congenital adrenal hyperplasia, Cushing syndrome, or polycystic ovary syndrome)

• Previous major uterine surgery (that would affect endometrial receptivity)

Secondary exclusion criteria

• <5 follicles at the time of trigger

• <2 full formed blastocyst on day 5 of embryo culture

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Hyperstimulation Syndrome
• Pregnancy

Intervention

Procedure:
• final oocyte maturation trigger
when =3 follicles reach 17mm patients will be randomized to receive one of two types of trigger for final oocyte maturation; dual trigger: GnRH agonist plus hCG (both full doses) hCG only: full dose of hCG only

Locations

Country	Name	City	State
Turkey	Antalya IVF	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Antalya IVF

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	clinical pregnancy	the number of patients with an ultrasound confirmed fetal heart 7 weeks after the transfer of embryos to patient uteruses	12 months	No
Primary	embryo implantation rate	the number of fetal sacs per embryo transferred to a patient's uterus	12 months	No
Secondary	oocyte maturation	the percentage of oocytes that are at the metaphase II (nuclear mature) stage at the time of oocyte collection	12 months	No
Secondary	Ovarian hyperstimulation syndrome	a complication arising from ovarian hyperstimulation with the use of exogenous hormones and ovulation induction	12 months	Yes