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Oral Dydrogesterone (OD) Versus Micronized Vaginal Progesterone (MVP) for Luteal Phase Support (LPS) in IVF/ICSI

Primary Purpose

Infertility, Female, Infertility, Genital Diseases, Male

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Dydrogesterone Oral Tablet
Micronized progesterone
Placebo Dydrogesterone oral tablet
Placebo Micronized progesterone
Sponsored by
CRG UZ Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Female

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Oocyte donor candidates
  • 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:

  • Intra-uterine device
  • 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

Sites / Locations

  • Centrum voor Reproductieve Geneeskunde

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Group l: 1st cycle MVP/placebo OD

Group ll: 1st cycle placebo MVP/OD

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Molecular endometrial level using illumina RNA-seq
To study the difference of OD versus MVP as LPS after controlled ovarian stimulation (COS) on the molecular endometrial level using Illumina RNA-seq on endometrial derived single cell suspensions
Molecular endometrial level using immunohistochemistry
To study the difference of OD versus MVP as LPS after controlled ovarian stimulation (COS) on the molecular endometrial level using immunohistochemistry on endometrial derived single cell suspensions
Molecular endometrial level using flow cytometry
To study the difference of OD versus MVP as LPS after controlled ovarian stimulation (COS) on the molecular endometrial level using flow cytometry on endometrial derived single cell suspensions

Secondary Outcome Measures

Difference in pharmacokinetic profile: Progesterone: AUC0-τ
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Difference in pharmacokinetic profile: Progesterone: AUC0-t
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Difference in pharmacokinetic profile: Progesterone: Cmax
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Difference in pharmacokinetic profile: Progesterone: tmax
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Difference in pharmacokinetic profile: Progesterone: Ctrough
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Difference in pharmacokinetic profile: Progesterone: λz
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Difference in pharmacokinetic profile: Progesterone: t1/2
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Difference in pharmacokinetic profile: Progesterone: CL/F
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Difference in pharmacokinetic profile: Progesterone: Vz/F
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: AUC0-τ
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: ratios of AUC0-τ of dydrogesterone and DHD
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: AUC0-t
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: ratios of AUC0-t of dydrogesterone and DHD
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: Cmax
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: ratios of Cmax of dydrogesterone and DHD
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: tmax
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: Ctrough
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: λz
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: t1/2
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: CL/F
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: Vz/F
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Difference in peripheral immunology
To study the effects of OD versus MVP on the peripheral immunology (using flow cytometry to investigate T regulatory and T effector cells derived from peripheral blood)
Difference in microbiota in the female genital tract
by cervical swab, a vaginal swab (posterior fornix) and an intra-uterine sample using an empty embryo catheter. Evaluation using 16S rRNA amplicon sequencing - Illumina miSeq

Full Information

First Posted
September 4, 2018
Last Updated
December 14, 2020
Sponsor
CRG UZ Brussel
Collaborators
Universitätsklinikum Hamburg-Eppendorf, Abbott, KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT03677336
Brief Title
Oral Dydrogesterone (OD) Versus Micronized Vaginal Progesterone (MVP) for Luteal Phase Support (LPS) in IVF/ICSI
Official Title
Oral Dydrogesterone Versus Micronized Vaginal Progesterone for Luteal Phase Support in In Vitro Fertilisation (IVF)/ IntraCytoplasmic Sperm Injection (ICSI): Pharmacokinetics and the Impact on the Endometrium, the Microbiota of the Genital Tract and the Peripheral Immunology. Double Blind Crossover Study.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
August 24, 2020 (Actual)
Study Completion Date
August 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CRG UZ Brussel
Collaborators
Universitätsklinikum Hamburg-Eppendorf, Abbott, KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Female inability to conceive a child. The purpose of this prospective randomized, double-blinded, double dummy, two-arm cross-over study is to investigate the difference on histological, transcriptional and immunological level in endometrium between 3x10mg Dydrogesterone oral tablets and 3x200 mg Micronized progesterone intravaginal capsules for the luteal support in egg cell donors. Beside that, the pharmacokinetics, the impact on the peripheral immunology (by blood sampling) and the microbiota (by genital swabs) will be investigated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female, Infertility, Genital Diseases, Male, Genital Diseases, Female, Progesterone, Dydrogesterone, Hormones, Hormones, Hormone Substitutes, and Hormone Antagonists, Physiological Effects of Drugs, Progestins

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
A randomised, cross-over, double blind double dummy study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Blinded and packaged medication will be provided to the investigational site and dispensed to the participants. The participants, their treating physicians and the investigators will be blinded for the randomization of subjects to the treatment groups. Of both treatment medications, OD and MVP, a placebo version will be available and administered in both oocyte donation cycles. The medication will be given in a double blind double dummy fashion. All the tablets and capsules will be identical in appearance, shape, smell and taste, and packaged in the proper proportion to assure desired dosages and maintenance of the blinding.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group l: 1st cycle MVP/placebo OD
Arm Type
Other
Arm Description
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.
Arm Title
Group ll: 1st cycle placebo MVP/OD
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dydrogesterone Oral Tablet
Other Intervention Name(s)
OD, Duphaston
Intervention Description
Tablet, oral, 10 mg, 3 times daily, starting on the day of oocyte retrieval in the morning and during 8 days
Intervention Type
Drug
Intervention Name(s)
Micronized progesterone
Other Intervention Name(s)
MVP, Utrogestan
Intervention Description
Capsule, vaginal, 200 mg, 3 times daily, starting on the day of oocyte retrieval in the morning and during 8 days
Intervention Type
Drug
Intervention Name(s)
Placebo Dydrogesterone oral tablet
Other Intervention Name(s)
Placebo OD
Intervention Description
Tablet, indistinguishable from dydrogesterone oral tablet
Intervention Type
Drug
Intervention Name(s)
Placebo Micronized progesterone
Other Intervention Name(s)
Placebo MVP
Intervention Description
Capsule, indistinguishable from micronized vaginal progesterone capsules
Primary Outcome Measure Information:
Title
Molecular endometrial level using illumina RNA-seq
Description
To study the difference of OD versus MVP as LPS after controlled ovarian stimulation (COS) on the molecular endometrial level using Illumina RNA-seq on endometrial derived single cell suspensions
Time Frame
On the eight day (at 8am) of LPS intake
Title
Molecular endometrial level using immunohistochemistry
Description
To study the difference of OD versus MVP as LPS after controlled ovarian stimulation (COS) on the molecular endometrial level using immunohistochemistry on endometrial derived single cell suspensions
Time Frame
On the eight day (at 8am) of LPS intake
Title
Molecular endometrial level using flow cytometry
Description
To study the difference of OD versus MVP as LPS after controlled ovarian stimulation (COS) on the molecular endometrial level using flow cytometry on endometrial derived single cell suspensions
Time Frame
On the eight day (at 8am) of LPS intake
Secondary Outcome Measure Information:
Title
Difference in pharmacokinetic profile: Progesterone: AUC0-τ
Description
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Time Frame
On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Title
Difference in pharmacokinetic profile: Progesterone: AUC0-t
Description
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Time Frame
On the first day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose.
Title
Difference in pharmacokinetic profile: Progesterone: Cmax
Description
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Time Frame
On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Title
Difference in pharmacokinetic profile: Progesterone: tmax
Description
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Time Frame
On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Title
Difference in pharmacokinetic profile: Progesterone: Ctrough
Description
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Time Frame
On the eight day of LPS intake: 1 hour before morning dose.
Title
Difference in pharmacokinetic profile: Progesterone: λz
Description
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Time Frame
On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Title
Difference in pharmacokinetic profile: Progesterone: t1/2
Description
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Time Frame
On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Title
Difference in pharmacokinetic profile: Progesterone: CL/F
Description
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Time Frame
On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Title
Difference in pharmacokinetic profile: Progesterone: Vz/F
Description
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Time Frame
On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Title
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: AUC0-τ
Description
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Time Frame
On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Title
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: ratios of AUC0-τ of dydrogesterone and DHD
Description
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Time Frame
On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Title
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: AUC0-t
Description
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Time Frame
On the first day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose.
Title
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: ratios of AUC0-t of dydrogesterone and DHD
Description
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Time Frame
On the first day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose.
Title
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: Cmax
Description
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Time Frame
On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Title
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: ratios of Cmax of dydrogesterone and DHD
Description
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Time Frame
On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Title
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: tmax
Description
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Time Frame
On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Title
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: Ctrough
Description
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Time Frame
On the eight day of LPS intake: 1 hour before morning dose.
Title
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: λz
Description
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Time Frame
On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Title
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: t1/2
Description
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Time Frame
On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Title
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: CL/F
Description
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Time Frame
On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Title
Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: Vz/F
Description
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
Time Frame
On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Title
Difference in peripheral immunology
Description
To study the effects of OD versus MVP on the peripheral immunology (using flow cytometry to investigate T regulatory and T effector cells derived from peripheral blood)
Time Frame
On the first and eight day of LPS intake, 1hour before morning dose at 9 am.
Title
Difference in microbiota in the female genital tract
Description
by cervical swab, a vaginal swab (posterior fornix) and an intra-uterine sample using an empty embryo catheter. Evaluation using 16S rRNA amplicon sequencing - Illumina miSeq
Time Frame
On the first and eight day of LPS intake, 1 hour before morning dose at 9 am.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Oocyte donor candidates 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: Intra-uterine device 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herman Tournaye, PhD, MD
Organizational Affiliation
Head of department CRG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centrum voor Reproductieve Geneeskunde
City
Jette
State/Province
Brussel
ZIP/Postal Code
1090
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28333318
Citation
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. Erratum In: Hum Reprod. 2017 Oct 1;32(10):2152.
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Oral Dydrogesterone (OD) Versus Micronized Vaginal Progesterone (MVP) for Luteal Phase Support (LPS) in IVF/ICSI

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