Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 27 of 2075 for:    ESTRADIOL

Luteal Phase Estradiol Support for In Vitro Fertilization/Intracytoplasmic Sperm Injection Cycles

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02677259
Recruitment Status : Unknown
Verified February 2016 by Dr. Evan Taerk, One Fertility.
Recruitment status was:  Not yet recruiting
First Posted : February 9, 2016
Last Update Posted : February 10, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Evan Taerk, One Fertility

Brief Summary:
Optimizing in vitro fertilization (IVF) success is more important than ever, in light of new public funding of IVF in Ontario, Canada. In patients undergoing IVF using gonadotropin-releasing hormone (GnRH) analogues, the luteal phase appears to be compromised, which may be a result of controlled-ovarian hyperstimulation, significant fluctuations in hormone levels, the impact of the oocyte retrieval process, or direct compromise of the corpus luteum. Progesterone support is definitely necessary during the luteal phase to facilitate implantation but whether estrogen supplementation is also needed remains unclear. The present study aims to determine whether estradiol support during the luteal phase improves clinical pregnancy rate in patients undergoing IVF.

Condition or disease Intervention/treatment Phase
IVF Drug: 17-beta estradiol Drug: Micronized progesterone Phase 2

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 506 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Luteal Phase Estradiol Support for In Vitro Fertilization/Intracytoplasmic Sperm Injection Cycles: a Randomized, Controlled Study
Study Start Date : May 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018


Arm Intervention/treatment
Experimental: Estradiol + Standard Luteal Phase Support
  1. 17-beta estradiol 3 mg PO/PV BID from day of oocyte retrieval until 6 weeks gestation
  2. Micronized progesterone 200 mg PV TID from day of oocyte retrieval until 10 weeks gestation
Drug: 17-beta estradiol
Other Name: Estrace

Drug: Micronized progesterone
Other Name: Endometrin

Active Comparator: Standard Luteal Phase Support
1. Micronized progesterone 200 mg PV TID from day of oocyte retrieval until 10 weeks gestation
Drug: Micronized progesterone
Other Name: Endometrin




Primary Outcome Measures :
  1. Clinical Pregnancy [ Time Frame: Assessed at 6 weeks gestation ]
    Presence of fetal heart activity on ultrasound at or beyond 6 weeks gestation.


Secondary Outcome Measures :
  1. Ongoing Pregnancy Rate [ Time Frame: Assessed at 12+1 weeks gestation ]
    Number of clinical pregnancies on ultrasound continuing beyond 12 weeks gestation/number of clinical pregnancies

  2. Implantation Rate [ Time Frame: Assessed at 6 weeks gestation ]
    Number of clinical pregnancies/number of embryos transferred

  3. Luteal phase serum estradiol and progesterone concentration [ Time Frame: Performed at oocyte retrieval, 10 days after retrieval, and at the time of serum pregnancy testing, i.e. 17 days after retrieval ]
  4. Miscarriage Rate [ Time Frame: Assessed at 6 - 20 weeks gestation ]
    Number of pregnancy losses before 20 weeks/number of clinical pregnancies

  5. Ectopic Pregnancy Rate [ Time Frame: Assessed at 6 weeks gestation ]
    Number of ectopic pregnancies on ultrasound/number of clinical pregnancies



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Indications for IVF/ICSI include male factor, diminished ovarian reserve, tubal factor, ovulatory dysfunction and unexplained infertility.

Exclusion Criteria:

  • none

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): NCT02677259


Contacts
Layout table for location contacts
Contact: Evan Taerk, MD,MSc 4167372033 evantaerk@gmail.com

Sponsors and Collaborators
One Fertility

Publications:

Layout table for additonal information
Responsible Party: Dr. Evan Taerk, One Fertility
ClinicalTrials.gov Identifier: NCT02677259     History of Changes
Other Study ID Numbers: 0564
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: February 10, 2016
Last Verified: February 2016
Keywords provided by Dr. Evan Taerk, One Fertility:
luteal phase
estradiol
pregnancy rate
Additional relevant MeSH terms:
Layout table for MeSH terms
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol
Polyestradiol phosphate
Progesterone
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Progestins