Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2020-06-08
2023-01-01
Brief Summary
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Design prospective randomized controled study Subjects Patients who underwent antagonist-based cycles performed in the "Shaare Zedek Medical Center" IVF clinic between 2020 and 2022 Intervention Intranasal GnRH-agonist or vaginal Progesterone for luteal support.
Main outcome measures Pregnancy and clinical pregnancy rates, ohss.
The study cohort included 150 patients who underwent 164 cycles. A total of 127 cycles were included. Of them, 64 were treated with GnRH-a and 63 with progesterone.
Hypothesis: This RCT suggests that GnRH-a for luteal phase support is associated with a higher positive β-hCG pregnancy rate and clinical pregnancy rate, compared with standard progesterone support in an antagonist-based protocol triggered with hCG, while maintaining a similar safety profile.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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GnRH-agonist group
In the GnRH-a group, LPS was initiated on the evening after the OPU, using Nafareline (Synarel nasal spray 200mg used once), followed by twice daily (total 400mg/day) until the day of serum β-hCG pregnancy test, and then stopped, regardless of the test results
GnRH agonist
GnRH agonist alone for luteal phase support in fresh IVF embryo transfer cycles
Progesterone group
In the progesterone group, LPS was initiated on the morning after OPU, using micronized progesterone ( PV Utrogestan 300mg, 3 times daily), until serum β-hCG pregnancy tests results were available. If a β-hCG pregnancy was confirmed, LPS was continued until the end of the 8th gestational week
Progesterone
vaginal progesterone for luteal phase support
Interventions
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GnRH agonist
GnRH agonist alone for luteal phase support in fresh IVF embryo transfer cycles
Progesterone
vaginal progesterone for luteal phase support
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
45 Years
FEMALE
Yes
Sponsors
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Shaare Zedek Medical Center
OTHER
Responsible Party
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Locations
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Shaare Zedek medical Center
Jerusalem, , Israel
Countries
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References
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Buhbut E, Nabulsi R, Avigdor G, Ben-Ami I. Comparison of pregnancy rates in antagonist cycles after luteal support with GnRH-agonist versus progesterone: prospective randomized study. Arch Gynecol Obstet. 2023 Jul;308(1):255-263. doi: 10.1007/s00404-023-07017-5. Epub 2023 Apr 25.
Other Identifiers
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Synarel fresh LPS
Identifier Type: -
Identifier Source: org_study_id
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