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

Kaohsiung Veterans General Hospital

Status: Completed

Conditions: Fertilization in Vitro

Treatments: Other: follicular ovarian stimulation; Other: luteal ovarian stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03238833

VGHKS15-CT11-12

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 96 patients

Sex: Female

Ages: 30 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Poor ovarian responders (PORs) met the Bologna criteria, having at least two of the three following features:

  1. advanced maternal age (≥ 40 years) or any other risk factor for POR,
  2. a previous POR (≤ 3 oocytes with a conventional stimulation protocol), and
  3. 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

luteal ovarian stimulation

Experimental group

Description:

The controlled ovarian stimulation in in vitro fertilization cycle was started since luteal phase.

Treatment:

Other: luteal ovarian stimulation

follicular ovarian stimulation

Active Comparator group

Description:

The controlled ovarian stimulation in in vitro fertilization cycle was started since early follicular phase phase.

Treatment:

Other: follicular ovarian stimulation