Oral Dydrogesterone (OD) Versus Micronized Vaginal Progesterone (MVP) for Luteal Phase Support (LPS) in IVF/ICSI
NCT ID: NCT03677336
Last Updated: 2020-12-17
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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COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2019-05-01
2020-08-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Group l: 1st cycle MVP/placebo OD
2 cycles of controlled ovarian stimulation, dual triggering, oocyte retrieval (OR) and LPS, with an interval period of 2 to 12 months. The only difference of the second cycle being the other LPS study medication as compared to the first cycle.
* 1st cycle: Start on day of oocyte retrieval (OR) (=d1): Dydrogesterone Oral Tablet 10 mg 3 times daily + Placebo micronized vaginal progesterone 200 mg capsules 3 times daily, for 8 days.
* 2nd cycle: Start on day of oocyte retrieval (OR) (=day 1): 'Micronized Progesterone 200 mg intravaginal capsules 3 times daily + placebo 'Dydrogesterone Oral Tablet 10 mg 3 times daily, for 8 days.
Dydrogesterone Oral Tablet
Tablet, oral, 10 mg, 3 times daily, starting on the day of oocyte retrieval in the morning and during 8 days
Micronized progesterone
Capsule, vaginal, 200 mg, 3 times daily, starting on the day of oocyte retrieval in the morning and during 8 days
Placebo Dydrogesterone oral tablet
Tablet, indistinguishable from dydrogesterone oral tablet
Placebo Micronized progesterone
Capsule, indistinguishable from micronized vaginal progesterone capsules
Group ll: 1st cycle placebo MVP/OD
2 cycles of controlled ovarian stimulation, dual triggering, oocyte retrieval (OR) and LPS, with an interval period of 2 to 12 months. The only difference of the second cycle being the other LPS study medication as compared to the first cycle.
* 1st cycle: Start on day of oocyte retrieval (OR) (=day 1): Micronized Progesterone 200 mg intravaginal capsules 3 times daily + placebo Dydrogesterone Oral Tablet 10 mg 3 times daily, for 8 days.
* 2nd cycle: Start on day of oocyte retrieval (OR) (=day 1): Dydrogesterone Oral Tablet 10 mg 3 times daily + Placebo micronized progesterone 200 mg intravaginal capsules 3 times daily, for 8 days.
Dydrogesterone Oral Tablet
Tablet, oral, 10 mg, 3 times daily, starting on the day of oocyte retrieval in the morning and during 8 days
Micronized progesterone
Capsule, vaginal, 200 mg, 3 times daily, starting on the day of oocyte retrieval in the morning and during 8 days
Placebo Dydrogesterone oral tablet
Tablet, indistinguishable from dydrogesterone oral tablet
Placebo Micronized progesterone
Capsule, indistinguishable from micronized vaginal progesterone capsules
Interventions
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Dydrogesterone Oral Tablet
Tablet, oral, 10 mg, 3 times daily, starting on the day of oocyte retrieval in the morning and during 8 days
Micronized progesterone
Capsule, vaginal, 200 mg, 3 times daily, starting on the day of oocyte retrieval in the morning and during 8 days
Placebo Dydrogesterone oral tablet
Tablet, indistinguishable from dydrogesterone oral tablet
Placebo Micronized progesterone
Capsule, indistinguishable from micronized vaginal progesterone capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Regularly cycling
* BMI ≥18 and ≤ 29 kg/m2
* Signed informed consent
* Non-smokers.
* AMH \<7,53 and \>1,18 ng/mL (90th and 10th percentile for healthy women aged 25-29 according to the used Elecsys® AMH kit by Roche)
* PRL, T and TSH within the normal limits for the clinical laboratory, or considered not clinically significant by the investigator within 6 months prior or at screening
Exclusion Criteria
* Previous enrollment
* Evidence of cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatologic/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurologic/psychiatric, allergy, recent major surgery (\< 3 months), or other relevant diseases as revealed by history, physical examination and/or laboratory assessments which could limit participation in or completion of the study
* Acute urogenital disease during the course of the study
* Known allergic reactions to progesterone / dydrogesterone products (active substance or to any of the excipients)
* Intake of any experimental drug or any participation in any other clinical trial within 30 days prior to study start.
* Mental disability or any other lack of fitness, in the investigator's opinion, to preclude subjects in or to complete the study.
* Current or recent substance abuse, including alcohol and tobacco (patients who stopped tobacco usage at least 3 months prior to screening visit would be allowed)
* Refusal or inability to comply with the requirements of the study protocol for any reason, including scheduled clinic visits and laboratory tests.
* Known or suspected progestogen dependent neoplasms (e.g. meningioma)
* Serum progesterone level \>1.5 ng/mL at ovulation triggering
18 Years
35 Years
FEMALE
Yes
Sponsors
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Universitätsklinikum Hamburg-Eppendorf
OTHER
Abbott
INDUSTRY
KU Leuven
OTHER
CRG UZ Brussel
OTHER
Responsible Party
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Mackens Shari
Principal investigator
Principal Investigators
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Herman Tournaye, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Head of department CRG
Locations
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Centrum voor Reproductieve Geneeskunde
Jette, Brussels Capital, Belgium
Countries
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References
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Tournaye H, Sukhikh GT, Kahler E, Griesinger G. A Phase III randomized controlled trial comparing the efficacy, safety and tolerability of oral dydrogesterone versus micronized vaginal progesterone for luteal support in in vitro fertilization. Hum Reprod. 2017 May 1;32(5):1019-1027. doi: 10.1093/humrep/dex023.
Other Identifiers
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2018-000105-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DYDRA001
Identifier Type: -
Identifier Source: org_study_id