Health TrialsbyHealthPanel

Clinical Study on ShouTai Pills for Improving Reduced Ovarian Reserve

ConditionDiminished Ovarian Reserve (DOR)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-50
SponsorPeking Union Medical College Hospital

About this trial

Grounded in the 'disease-syndrome combination' paradigm, this study endeavors to address the pivotal scientific issues pertaining to the clinical precision of Traditional Chinese Medicine (TCM) in managing Diminished Ovarian Reserve (DOR) classified as the Kidney Essence Deficiency type, through the application of systems biology technologies, including metabolomics.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The inclusion criteria are as follows: ① meeting the above-mentioned integrated Chinese and Western medicine diagnostic criteria for DOR

② no use of estrogen-containing medications within the past 1 month

③ patients scheduled to undergo IVF-ET

④ provision of signed informed consent, voluntary participation, and good compliance.

Disqualifiers

The exclusion criteria are as follows: ① patients with polycystic ovary syndrome (PCOS) or stage III/IV endometriosis

② uterine conditions including untreated submucous myomas, intramural myomas >4 cm in diameter, intrauterine adhesions, uterine septum, or other uterine anomalies

③ couples undergoing preimplantation genetic diagnosis (PGD) for genetic reasons

④ body mass index (BMI) ≥28 kg/m²

Trial design

Design model

Parallel

Treatments tested in this trial

  • Shoutai Pill

    Drug

    The experimental group took Shoutai Pills, 20 pills each time, twice daily, taken with water, continuously for 3 months

  • Placebo

    Drug

    The experimental group took placebo Pills, 20 pills each time, twice daily, taken with water, continuously for 3 months

Treatment groups

136 Participants
are divided into 2 treatment groups
Group A: Shoutai PillExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of MII oocyte

On the day of oocyte retrieval, the number of mature oocytes was observed under a microscope. Mature oocytes are defined as oocytes containing the first polar body.

Time frame
After 3 months of medication, ovulation induction was performed, followed by oocyte retrieval upon completion of the induction cycle. The number of mature oocytes was recorded on the day of retrieval.

Secondary outcomes

1

FSH

Follicle-Stimulating Hormone

Time frame
Basline， and after 3 months of treatment
2

AMH

Anti-Müllerian Hormone

Time frame
Basline， and after 3 months of treatment
3

number of oocytes retrieved

Direct visualization under microscopy

Time frame
After 3 months of medication, ovulation induction was performed, followed by oocyte retrieval upon completion of the induction cycle. The number of mature oocytes was recorded on the day of retrieval.
4

AFC

antral follicle count

Time frame
Basline， and after 3 months of treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking Union Medical College Hospital

Lead sponsor

Beijing Municipal Health Commission

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: