Agonist Trigger With HCG Luteal Supplementation vs HCG Trigger With Progesterone Luteal Supplementation in Antagonist Controlled HyperstimulationCycle

Ain Shams University

Status: Completed

Conditions: Infertility, Female

Treatments: Drug: Progesterone; Drug: hCG; Drug: Triptorelin

Study type: Interventional

Funder types: Other

Identifiers

NCT04846218

AP-45WE

Details and patient eligibility

About

The aim of the current study is to compare agonist trigger and HCG luteal support vs standard HCG trigger and progesterone luteal supplementation in antagonist controlled hyperstimulation cycle as regards to clinical pregnancy rate.

Full description

Prospective Interventional randomized pilotstudy on patients undergoing controlled ovarian hyperstimulation.

All patients will receive a fixed dose of 150-300 IU recombinant FSH (Gonal-F; Sereno Laboratories,Madrid, Spain) for ovarian stimulation according to age, BMI and antral follicle count (AFC).

After 6 days of stimulation, FSH will be adjusted according to ovarian response.

Premature LH surge will be prevented with 0.25 mg of a GnRH antagonist (Cetrotide; Serono International, Geneva, Switzerland) starting on day 6 when two or more follicles reach a size of 18-20 mm, trigger of ovulation will be done and followed by luteal phase support according to the protocol assigned for each group.

Group 1:

A single dose of 0.2 mg triptorelin (Decapeptyl® Ipsen Pharmaceutical Company, France) and follow up with daily 125 IU HCG injections

Group 2:

A single dose of HCG 10000 IU was given followed by progesterone supplementation with 100mg IM (Prontogest®).

Enrollment: 100 patients

Sex: Female

Ages: 20 to 39 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 20 and 39 years.
• Body mass index between 18 and 30.
• Unexplained infertility or male factor infertility

Exclusion criteria

• Endocrinological disorder eg.:hyperprolactenemia, Hypo or hyper thyrodism
• More than 2 previous attemptsof IVF
• Any uterine anatomical anomaly.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Group 1

Active Comparator group

Description:

They will receive a single dose of 0.2 mg triptorelin (Decapeptyl® Ipsen Pharmaceutical Company, France) and follow up with daily 125 IU HCG injections

Treatment:

Drug: Triptorelin

Drug: hCG

Group 2

Active Comparator group

Description:

They will receive a single dose of HCG 10000 IU was given followed by progesterone supplementation with 100mg IM (Prontogest®).

Treatment:

Drug: Progesterone

Drug: hCG