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A Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Crinone 8% Intravaginal Progesterone Gel 90 mg Daily for Luteal Support in In-Vitro Fertilization (LOTUS II) (LOTUS II)

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ClinicalTrials.gov Identifier: NCT02491437
Recruitment Status : Completed
First Posted : July 8, 2015
Last Update Posted : October 6, 2017
Sponsor:
Collaborators:
PRA Health Sciences
Datamap
Information provided by (Responsible Party):
Abbott

Brief Summary:

The purpose of this randomized, two-arm and open label study is to demonstrate that the treatment of a daily dose of 3x10mg dydrogesterone orally is as effective and safe as the daily dose Crinone 8% intravaginal progesterone gel 90 mg for the luteal support in women who are unable to conceive a child and are undergoing IVF. The treatment will start on the day of oocyte retrieval and continue until pregnancy is negative or until week 12 gestation.

Patients will be followed during treatment until 30 days after delivery to record any safety and tolerability data of the patient and their newborn (s).


Condition or disease Intervention/treatment Phase
Female Infertility Drug: Dydrogesterone 30 mg Drug: intravaginal progesterone gel 90 mg Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1066 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Two-arm, Multicenter Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Crinone 8% Intravaginal Progesterone Gel 90 mg Daily for Luteal Support in In-Vitro Fertilization (LOTUS II)
Study Start Date : July 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Experimental: Dydrogesterone tablets 3x10 mg
Dydrogesterone tablets 3x10 mg
Drug: Dydrogesterone 30 mg
Oral Dydrogesterone 10 mg tablets tid

Experimental: Crinone 8% intravaginal progesterone gel 90 mg
Crinone 8% intravaginal progesterone gel 90 mg
Drug: intravaginal progesterone gel 90 mg
Other Name: Crinone 8% intravaginal progesterone gel 90 mg




Primary Outcome Measures :
  1. Pregnancy rate [ Time Frame: 12 weeks´ gestation ]
    Pregnancy rate defined as the presence of fetal heart beats at 12 weeks' gestation determined by transvaginal ultrasound.


Secondary Outcome Measures :
  1. Positive Pregnancy test rate [ Time Frame: Day 14 after embryo transfer ]
    Positive biochemical pregnancy test on Day 14 after embryo transfer

  2. Rate of successful completion of pregnancy [ Time Frame: After delivery (about 9 months after IVF) ]
    Incidence of live births and healthy newborns

  3. Adverse Events [ Time Frame: Until Study Completion (about 10 months after IVF) ]
    Safety and Tolerability data (mother and child)

  4. physical examination newborn [ Time Frame: After delivery (about 9 months after IVF) ]
    The gender

  5. physical examination newborn [ Time Frame: After delivery (about 9 months after IVF) ]
    APGAR score

  6. physical examination newborn [ Time Frame: After delivery (about 9 months after IVF) ]
    height

  7. physical examination newborn [ Time Frame: After delivery (about 9 months after IVF) ]
    weight

  8. physical examination newborn [ Time Frame: After delivery (about 9 months after IVF) ]
    head circumference

  9. physical examination on hypospadias of the newborns [ Time Frame: After delivery (about 9 months after IVF) ]


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Ages Eligible for Study:   19 Years to 41 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent;
  • Premenopausal females, age > 18 years < 42 years
  • Non-smokers. For females who were past smokers, they must have stopped tobacco usage for at least 3 months prior screening visit
  • Early follicular phase (Day 2-4) FSH (Follicle stimulating hormone) less than or equal to 15 IU/L and estradiol (E2)within normal limits at screening
  • LH (luteinizing hormone), PRL (prolactin), T (testosterone) and TSH (thyroid-stimulating hormone), within the normal limits for the clinical laboratory, or considered not clinically significant by the Investigator within 6 months prior or at screening
  • Documented history of infertility (e.g., unable to conceive for at least one year or for 6 months for women ≥ 38 years of age or bilateral tubal occlusion or absence)
  • Normal transvaginal ultrasound at screening (or within 14 days prior of screening) without evidence of clinically significant abnormality consistent with finding adequate for ART with respect to uterus and adnexa (no hydrosalpinx or clinically relevant uterine fibroids)
  • Subject is not pregnant , confirmed by negative pregnancy or by Investigator Judgement
  • Clinically indicated protocol for induction of IVF with a fresh embryo
  • Single or dual embryo transfer
  • BMI ≥ 18 and ≤ 30 kg/m2

Exclusion Criteria:

  • 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
  • Known allergic reactions to progesterone products
  • Known allergic reactions to peanuts and peanut oil
  • Intake of àny 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 to participate in or to complete the study
  • Current or recent substance abuse, including alcohol and tobacco (Note: Patients who stopped tobacco usage at least 3 months prior to screening visit would be allowed)
  • History of chemotherapy or radiotherapy
  • Patients with more than 3 unsuccessful IVF attempts
  • Contraindication for pregnancy
  • Refusal or inability to comply with the requirements of the study protocol for any reason, including scheduled clinic visits and laboratory tests
  • History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages Acute urogenital disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02491437


  Show 40 Study Locations
Sponsors and Collaborators
Abbott
PRA Health Sciences
Datamap
Investigators
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Study Director: Shreyansh Shah, MD Abbott

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT02491437     History of Changes
Other Study ID Numbers: M13-625
2012-002993-29 ( EudraCT Number )
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
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Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female
Progesterone
Dydrogesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs