Acupuncture for Treatment of Patients With Poor Ovarian Response

NCT04013984 | Completed DMC

• 1 other identifier: POR-accupuncure
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized controlled trial is designed to investigate the effect of acupuncture on IVF/ICSI outcome in women with poor ovarian response. The study population consisted of all infertile women with a previous poor ovarian response who will undergo IVF/ICSI in Reproductive Biomedicine Research Center, Royan institute, Tehran Iran. To minimize the effect of ovarian stimulation protocol, a stratified randomization method according to ovarian stimulation protocols (GnRH agonist stopped and GnRH antagonist) is used.

Conditions

Poor Ovarian Response; Accupuncture

Outcome Measures

Primary Outcomes (3)

• Total number of retrieved oocytes

  At the point of ovum pick-up, we can count total number of retrieved oocytes. Therefore, in one hour after ovum pick-up, outcome measurement will be possible.

  Day of oocyte pick-up, 34-36 hours after hCG administration (approximately Stimulation Day 10)

• Oocyte maturity

  At the point of ovum pick-up, we can count how many mature or immature oocytes were retrieved. Therefore, in one hour after ovum pick-up, outcome measurement will be possible.

  Day of oocyte pick-up, 34-36 hours after hCG administration (approximately Stimulation Day 10)

• Quality of obtained embryos

  Embryo grade assessed under invert microscope 3 days after intracytoplasmic sperm injection procedure \[ Time Frame: 3 days after intracytoplasmic sperm injection procedure \] Embryo grade assessed under invert microscope 3 days after intracytoplasmic sperm injection procedure.The quality of embryos was graded from 1 to 3 under inverted microscope 3 days after intracytoplasmic sperm injection procedure. Embryos with even-sized blastomers and/or \<5% fragments were classified as Grade 1 (good quality). Grade 2 embryos (moderate quality) had blastomeres with slightly-moderate size differences and/or 5-50% fragments. Grade 3 embryos (poor quality) had markedly different-sized blastomers and/or \>50% fragments.

  3 days after IVF/ICSI procedure

Secondary Outcomes (2)

• Implantation rate

  4 weeks after embryo transfer

• Clinical pregnancy rate

  4-6 weeks after embryo transfer

Study Arms (2)

Accupuncture

EXPERIMENTAL

Acupuncture twice a week during the preceding cycle and the ovarian stimulation by "GnRH agonist stopped protocol".

Other: Accupuncture

Non-accupuncture

NO INTERVENTION

Ovarian stimulation by" GnRH agonist stopped protocol" without intervention.

Interventions

Accupuncture OTHER

In experimental groups (A), acupuncture will be applied for 30 minutes in each session and will be started from the month prior to onset of ovarian stimulation (two sessions of a weekly), and during the ovarian stimulation cycle (two sessions of a weekly), totally 7 acupuncture sessions will be carried out. Acupuncture will be performed using sterile needle on specific points (CV 3 (Zhongji), CV 4 (Guanyuan), ST 25 (Tianshu), ST 28 (Shuidao), ST 29 (Guilai), and LR 3 (Taichong), BL 23 (Shenshu), BL 32 (Ciliao), GV 20 (Baihui), GV 24 (Shenting), GB 13 (Benshen), ST 36 (Zusanli), SP 6 Sanyinjiao), SP 8, SP 10 and KI 3 (Taixi)). The needles were inserted to a depth of 15-30 mm, depending on the region of the body. No sham acupuncture is considered in the control group for ethical and practical reasons

Accupuncture

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of Poor ovarian response (POR), according to POSSEIDON group criteria (Group 3) Young patients (\<35 years) with poor ovarian reserve prestimulation parameters (AFC \<5, AMH\<1.2 ng/mL).

You may not qualify if:

• Premature ovarian failure diagnosis.
• Endometriosis grade III or IV.
• Any contraindications to ovarian stimulation treatment.
• Uterine infertility factor.
• Previous history of ovarian surgery.

Sponsors & Collaborators

• Royan Institute: lead

Study Sites (1)

Royan Institute

Tehran, 16635-148, Iran

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: July 10, 2019
• Study Start: October 1, 2018
• Primary Completion: January 20, 2021
• Study Completion: January 20, 2022
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)