Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT04846218
Status:
COMPLETED
Last Update Posted:
2021-11-18
First Post:
2016-12-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Agonist Trigger With HCG Luteal Supplementation vs HCG Trigger With Progesterone Luteal Supplementation in Antagonist Controlled HyperstimulationCycle
Sponsor:
Ain Shams University
Organization:
Study Overview
Official Title:
Comparison Between Agonist Trigger With HCG Luteal Phase Supplementation vs HCG Trigger With Progesterone Luteal Phase Supplementation in Antagonist Controlled HyperstimulationCycle Regarding Clinical Pregnancy Rate
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed 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®).
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®).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: