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OpenTrials
Completed

NCT Number: NCT03238833

Poor Ovarian Responders Undergoing IVF Using Luteal Ovarian Stimulation Versus Follicular Ovarian Stimulation

The investigators attempted to compare the clinical outcomes and cumulus genes expression in poor ovarian responders undergoing luteal ovarian stimulation or follicular ovarian stimulation in in vitro fertilization cycles.

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Key information

Age range

30 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

About this study

Multiple follicular wave theory proposed by Baerwald et al. implied that follicle recruitment may occur in the luteal phase of menstrual cycle. Therefore, luteal phase ovarian stimulation (LPOS) was considered as a potential feasible stimulation method during in vitro fertilization (IVF) cycle. In the beginning, in order to avoid delaying cancer treatment, LPOS was applied for fertility preservation of cancer patients, showing no difference in numbers of oocyte retrieved, mature oocytes and fertilization rate between luteal or follicular phase stimulation. In the recent, LPOS was used for infertility women, suggesting that LPOS owned quite good IVF outcomes. In previous studies, premature luteinizing hormone (LH) surge, a major reason worsening ovarian quality in poor ovarian responders (PORs), was seldom found in LPOS. High progesterone in luteal phase may aid in suppressing premature LH surge. An updated research claimed that numbers of oocyte retrieved, mature oocytes and fertilized oocytes in LPOS significantly increased when compared to follicular ovarian stimulation. Therefore, the investigators presumed that LPOS was a more effective method than follicular stimulation in PORs.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Poor ovarian responders (PORs) met the Bologna criteria, having at least two of the three following features:
  • advanced maternal age (≥ 40 years) or any other risk factor for POR,
  • a previous POR (≤ 3 oocytes with a conventional stimulation protocol), and
  • an abnormal ovarian reserve test. An abnormal ovarian reserve test was defined as antral follicle count (AFC) < 5 or anti-Müllerian hormone (AMH) < 1 ng/mL in this study.

Moreover, two episodes of a previous POR after maximal stimulation alone would be sufficient to define a patient as a POR.

Exclusion criteria

  • oophorectomy
  • exposure to cytotoxic or pelvic irradiation for malignancy
  • taking herbal drugs or other hormonal agents

Treatment and study plan

luteal ovarian stimulation

Other

In the in vitro fertilization cycle, controlled ovarian stimulation was started since the luteal phase.

follicular ovarian stimulation

Other

In the in vitro fertilization cycle, controlled ovarian stimulation was started since the follicular phase.

Primary outcomes

  1. oocytes and embryos

    Time frame: through study completion, an average of 1 year

    retrieved oocytes in number, matured oocytes in number, fertilized oocytes in number, day 3 embryos in number, top-quality day 3 embryos in number

Secondary outcomes

  1. pregnancy rate

    Time frame: Pregnancy will be confirmed 4 weeks after embryo transfer.

    Clinical pregnancy rate

  2. genes expression

    Time frame: through study completion, an average of 1 year

    cumulus cells genes expression

Sponsors and collaborators

Lead sponsor

Kaohsiung Veterans General Hospital.

Other

Registry information

Official study title

Department of Obstetrics and Gynecology, Kaohsiung Veterans General Hospital

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 3, 2017
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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